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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 groups in fracture translations (Fracture migration of the femoral head/neck segment relative to the trochanteric region displayed as means with 95% confidence intervals (CI 95%) at 6-week (The postoperative stereoradiograph constitute the baseline reference for the fracture migration calculations*Statistical comparison of translations and rotations at 6 weeks, 3 months and 6 months with reference to the baseline examination (day 1)Thus, during the impaction phase (the first 6 weeks), the fractures settled with a fracture impaction (y-translation) of mean 5.95 mm (CI 95% 2.87 to 9.04), the femoral head/neck segment rotated anteriorly about the axis of the screw (y-rotation) by mean 2.94° (CI 95% − 5.22 to − 0.66), and the femoral head/neck translated distally (x-translation) by mean − 1.11 mm (CI 95% − 1.87 to − 0.34), with the trochanteric region as reference (Table Fracture migration in mm and fracture rotation in degrees of from baseline to 6 weeks (fracture impaction) and from 6 weeks to 6 months (fracture stabilization)Only patients with both 6 weeks data and 6 months data are included (*Statistical comparison between translations and rotations of the fracture impaction phase and the fracture stabilization phaseGraphs displaying the mean (CI 95%) fracture migration and rotations of the femoral head/neck segment with reference to the trochanteric region displayed as During the stabilization phase (6 weeks to 6 months), the fracture impaction (y-translation) was mean 0.89 mm (CI 95% 0.03 to 1.75) and femoral head/neck posterior rotation (y-rotation) was mean 0.22° (CI 95% − 1.36 to 1.80), which was less compared to the impaction phase ( | 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 fractures. Moreover, fracture migration was observed primarily in the first 6 weeks after surgery as femoral head distal migration, anterior rotation, and fracture impaction. | 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 [The biomechanical aspects of rotational stability have been debated for several years in patients with pertrochanteric fractures [Fracture reposition to anatomical position is attempted during surgery but can be difficult. Ragnarsson et al. studied RSA measured migration of displaced femoral neck fractures and found that intermediate fragments increased fracture instability due to poor bony contact, and that ad latum displacement of more or equal to 1 mm on either AP or LAT radiographic projection increased the risk for non-union [ | 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 manuscript revision. KH contributed to study planning and data collection and manuscript revision. MTK contributed to study planning, data collection and manuscript revision. HP contributed to study planning and approvals, funding, data collection, surgery and manuscript revision. MS contributed to study planning and approvals, surgery, data collection, image analysis, statistical analysis and data interpretation, writing of the original draft and manuscript revision. | 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. Therefore, this study aimed, in a rigorous three-armed design, to evaluate the effect of PIs on chronic pelvic pain (CPP) and QoL in women with endometriosis. | 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 (MY-ENDO), (2) Carefully matched non-specific psychological intervention (Non-specific), or (3) A wait-list control group (WL). The primary outcome was pelvic pain intensity/unpleasantness measured on NRS. Secondary outcomes included endometriosis-related quality of life, workability, pain acceptance, and endometriosis-related symptoms. Differences in outcomes between groups at post-treatment follow-up were analyzed using mixed linear models. Analyses were performed on an intention-to-treat basis. | 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 ‘constipation’. MY-ENDO was not superior to Non-specific. | 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 the pain and improving the quality of life of these women. This study aimed to examine whether a psychological treatment can improve pain and quality of life in women suffering from painful endometriosis. In addition, the study examines whether The study demonstrated that psychological intervention does not lead to pain reduction in women with endometriosis. However, it significantly improved the quality of life of these women despite an ongoing experience of severe chronic pelvic pain. It also improved the endometriosis-related symptoms “constipation” and “pain during defecation”. Therefore, the study indicates that psychological intervention may be an appropriate strategy to manage symptoms and improve the quality of life in women with endometriosis, but a definitive decision on the preferred psychological modality (Mindfulness- and acceptance-based psychological intervention as compared to Non-specific psychological intervention) cannot be made. More research is needed before we can conclude whether one specific psychological intervention is to be preferred to best manage symptoms and improve the quality of life in women suffering from painful endometriosis. | 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 medication, and/or surgical resection of endometrial lesions. Despite such treatment, recurrence and development of chronic pain problems are frequent [Consequently, we conducted a three-armed RCT to test the effects of (1) a specific PI (MY-ENDO), (2) a matched non-specific PI (Non-specific) and (3) a waitlist control (WL) on CPP and QoL in women with endometriosis. The hypothesis was to find statistically significant improvements in CPP and a number of secondary outcomes for (1) PI (MY-ENDO + Non-specific) compared to WL and for (2) MY-ENDO compared to Non-specific. | 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 improvement, but did not include the assumed specific ingredient, mindfulness or (3) A WL that involved treatment, as usual, to control for the natural fluctuations in pain [The study was preregistered with The Danish Data Protection Agency (journal no. 2015-57-0002), approved by The Central Denmark Region Committees on Health Research Ethics (registration no. 1-10-72-138-15), and retrospectively registered at clinicaltrials.gov (NCT02761382). Data was collected from March 2016 to October 2018. | 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-confirmed endometriosis diagnosis, (c) moderate to severe CPP (i.e., an average of ≥ 5 measured on an 11-point Numerical Rating Scale (NRS) from 0 = no pain to 10 = worst pain imaginable), (d) relevant clinical and surgical treatment according to the European Society of Human Reproduction and Embryology (ESHRE) guidelines for endometriosis [ | 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 randomization. Patients were informed that they would be randomized to one of two different psychological interventions or a waitlist control group. This should keep participants blinded to the psychological method and intervention content in the comparison group. To keep the research group blinded to intervention assignment throughout data collection, a research assistant, not part of the research group, provided patients with an anonymous id-number used for data collection. The numbers were randomized in blocks of six by another research assistant using a computer-generated randomization list.Questionnaires were sent to participants by postal mail, filled out, and returned. Baseline measurements were obtained during the 2 weeks period prior to treatment start, and post-intervention measurements were obtained during the 2 weeks post-treatment period. At home, patients also completed a 12-week pain diary starting 1 week pre-intervention until 1-week post-intervention. To investigate potential changes in pain processing and sensibility a female doctor carried out a gynecological experimental pain assessment during the 2-week period prior to treatment start and again during the 2 weeks post-treatment. However, the experimental pain assessment was optional and not required for participation (See Fig. Study timeline | 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 corresponding therapeutic actions, and (3) to be delivered by trained therapists in a healing context with expectations that the therapy would be beneficial [ | 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 study. | 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 score is standardized on a range from 0–10, defined by a mean of M = 6.0 and the standard deviation (SD) = 1.5. With the reasonable assumptions: Mean | 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 = 22.41 min/day, SD = 20.93) and Non-specific (Mean = 22.26 min/day, SD = 15.47) in the average amount of time (min/day) spent on homework during the 10-week treatment period ( | 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 medication” | 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 interventions have found that in a range of chronic pain conditions, lasting on average 9 years, Cognitive and Behavioral Therapy (CBT) shows small benefits in pain compared to active control conditions. Behavioral Therapy and ACT did not show such effects [The present study also found significant improvements in the endometriosis-related symptoms “dyschezia” and “constipation”. Studies indicate that bowel symptoms are frequent in endometriosis with interruptions in daily functioning [Contrary to the majority of previous studies comparing mindfulness- and acceptance-based intervention to an active control [ | 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., balancing therapist training, adherence, and competence; controlling for therapist effects; ensuring an equal treatment structure across conditions; and balancing non-specific factors) entails that the findings of this study may be highly robust.According to the power analysis we needed 81 participants to be able to detect significant differences in the primary outcome. Despite a smaller sample size, significant differences were found between the groups for the primary outcome While the small sample size would contribute considerably to the risk of type 2 error, one should also bear in mind that a large number of statistical tests were performed in the study, and hence there is considerable risk of type 1 error. Still, some interesting significant pre-post changes were found in our data including increased workability and lower fatigue in the MY-ENDO group. However, these effects did not show statistically significant differences between the groups, and larger sample sizes are needed in future studies to answer questions about specificity.Recruiting participants was difficult due to patients suffering from physical disabilities and lack of energy making the 3-h in-person commitment a barrier to participation. Other barriers were geographical distance and working schedules.Future studies could try new ways to overcome these limitations for example by stratifying participants by use of pain medication and offering digitally delivered therapy to this patient group. | 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. All authors read and approved the final manuscript and agree to be accountable for all aspects of the work. | 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 originating from six different Swedish hospitals, but to ensure the highest level of cost control, this analysis is limited to the 92 patients included at Örebro University Hospital. The inclusion criteria were a chronological age of more than 48 h, a gestational age above 36 + 0 weeks and a TSB above 18 mg/dl (300 µmol/L) between 48–72 h of age or TSB above 20.5 mg/dl (350 µmol/L) after 72 h of age. The exclusion criteria were blood group incompatibility, TSB at inclusion above 24 mg/dl (400 µmol/L), asphyxia, weight loss of more than 10%, an ongoing infection or any other severe illness.After we received informed consent from parents, all patients were randomized in a block-wise design to either phototherapy at home using the Bilisoft fiber optic device (GE healthcare, Chicago IL, USA) or to standard in-hospital phototherapy. Details of the inclusion process can be seen in the CONSORT flow diagram (Fig. CONSORT Flow diagram. | 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 achieving one more unit of the effect. In this analysis, time until success of treatment was measured as time from first to last test. Since there was no significant difference in duration of phototherapyWe performed sensitivity analysis by bootstrapping to acknowledge sampling uncertainty in both costs and effects. This procedure accounts for the variance in the study data by drawing repeated random samples with replacement of costs and effects from the intervention and control groups, with a sample size corresponding to the original sample. We drew 1000 sample pairs and estimated the average costs and effects for each. We also performed a deterministic sensitivity analysis, varying one variable while keeping the other constant, which allowed for uncertainty in cost estimations while facilitating generalizability to settings other than Sweden. | 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 costs.No discounting was applied due to the short-term character of the intervention.For both groups, the costs include hospital care days, outpatient re-visits, blood sampling, and consumables needed to use the Bilisoft equipment. We assumed no extra cost for the phototherapy equipment, as both groups used the same equipment for the same duration of treatment. Number of hospital care days is a measurement of the actual time spent in hospital. Length of stay was defined as time from the first to the last bilirubin test meaning that both in hospital and outpatient care is included. Duration of phototherapy was the actual time the patient spent on phototherapy. In this study, all families were admitted to a family room in the neonatal unit, but since phototherapy patients often are cared for in the maternity unit, we present estimates for both of these costs in the results.Transportation distance was based on the distance between the hospital and the families’ postcode. All families were assumed to travel by car. The number of round trips was registered in the study for both groups; the marginal cost per km traveled was based on the compensation offered by healthcare for car travel to and from the hospital for treatment. This might underestimate the real cost, as the full cost might not be covered. However, not all of those included in the study would have traveled by car as some lived near the hospital. Also, cost and expenses are not equal: fuel taxes are only transferred within the society and should therefore be excluded.No production loss was assumed, since both parents are allowed to claim compensation for caring for a sick child during treatment. This applies to both hospital and in-home phototherapy. Furthermore, no value or cost was assumed for time since there is no empirical evidence on the relative value of time spent at home, in hospital, or in transportation. | 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. having a shorter treatment duration; however, the 60% of drawings with shorter hospital than at-home treatments showed that each reduced hour cost on average €600 when infants were treated at the maternity unit (implying a higher cost at the neonatal unit). In 65% of the drawings, the difference in treatment duration was ± 12 h. Fewer than 5% of the drawings showed differences > 24 h.Deterministic analysis shows that transportation costs would need to be multiplied by 100 to change the recommendation by making hospital treatment at the maternity unit less expensive than treatment at home. If treating infants at the neonatal unit, transportation costs would have to be multiplied by more than a factor of 200 to be less expensive than treatment at home. Furthermore, outpatients visits would have to cost 10 times more per infant treated for home phototherapy to equal the cost of hospital treatment at the maternity unit, and more than 20 times higher to be as expensive as treatment at the neonatal unit. | 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 manuscript. All authors read and approved the final manuscript. | 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 acute natural defence to a potentially harmful stimulus. However, the continuous and sustained production of such pro-inflammatory compounds results in a state of chronic inflammation, which can be damaging to the body. Chronic inflammation is suggested to be an underlying pathophysiological risk factor for a range of chronic diseases, including cancers [In 2009, an evidenced-based tool was created, which was later updated and validated with the ability to categorize an individual’s diet as either pro-inflammatory or anti-inflammatory [ | 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), saturated fat (SFA, g), polyunsaturated fat (PUFA, g), omega-6 PUFA (mg), omega-3 PUFA (mg), fibre (g), cholesterol (mg), folic acid (µg), total folate (µg), iron (mg), magnesium (mg), zinc (mg), thiamine (mg), riboflavin (mg), niacin-eq. (mg), vitamin A (RE), vitamin C (mg), vitamin D (µg), vitamin E (mg), β-carotene-eq. (µg), flavanols (mg), flavones (mg), flavonols (mg), flavanones (mg), anthocyanidins (mg), isoflavones (mg), alcohol (g), caffeine (mg), garlic (g), ginger (g), onion (g), black tea (g), green tea (g), pepper (g), thyme/oregano (mg), and rosemary (mg). | 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, flow mediated dilatation). DII was divided into tertiles to establish low (most anti-inflammatory), medium, and high inflammatory dietary patterns. Univariate ANOVA was used to test for differences in health variables with the DII tertile as the fixed-factor variable. Where there was a significant effect, post hoc comparisons were performed with Bonferroni’s adjustments for multiple comparisons to determine differences between group means. | 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 “normal to elevated SBP (<140 mmHg) ( | 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 (tertile 1: Low) included DIIThere was a significant difference in average baseline BMI between both the lowest and middle DII tertiles and the highest tertile (Similarly, average body weight differed significantly from the two lower tertiles to the highest tertile (Blood lipids did not significantly differ across the different tertiles of DII in the raw model. When controlling for energy and total cholesterol, TGs and LDL-C remained non-significant across tertiles; however, HDL-C and consequently total:HDL-C showed significant differences (There was no significant association found between hsCRP, FWhen analysed with the E-DII model, SBP was significantly higher for those with a more pro-inflammatory DII | 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 found, except for a subset of participants with elevated SBP at baseline. A baseline cross-sectional analysis revealed significant differences between the highest (most inflammatory) and lowest (least inflammatory) E-DII tertiles. Those in the highest tertile of DII had higher average BMI, body weight, WHR, abdominal adiposity, and SBP, and lower HDL-C. No significant associations between hsCRP, FPrevious studies have demonstrated the association between MedDiet adherence and DII. A 2018 Australian cohort study including over 40,000 participants reported an inverse relationship between MedDiet adherence and DII scores [Our analyses reveal an association between dietary inflammatory potential and various parameters of obesity including BMI, abdominal adiposity, waist circumference, and WHR. Cross-sectional and longitudinal studies in the area failed to reach consensus on the topic. In line with our results, in the previously mentioned PREDIMED study, participants in the highest DII quintile had higher average WC and WHR compared to those in the lowest quintile. In female participants, this relationship was also reported with BMI [At present, the literature supports a significant association between a pro-inflammatory diet, with a higher DII/E-DII, and CVD risk factors, events, and mortality [During our initial investigations looking at between-group differences, we identified a small sub-group of participants allocated to the HabDiet group with initial elevated BP at baseline (Our study has several strengths. First, to our knowledge, this is the first study investigating the effect of a DII lowering dietary intervention on cardiometabolic outcomes in healthy older adults. Second, the use of 3-day weighed food records allows for a more accurate representation of participant diet. The more detailed records allow for the use of 40 of the 45 food parameters used to calculate DII, whereas some previous studies used 20–35 parameters [Despite its strengths, this study also has limitations. This was not the primary aim of the MedLey study, and with the sample size ( | 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 inflammatory load of the diet in this trial suggests a mechanism by which a MedDiet pattern could improve cognitive and cardiovascular health. This suggests that increasing compliance with this diet could be reductive or preventative in the elderly for these and other chronic health conditions, which may be useful for clinical practice. The baseline analyses provide additional affirmation of the relationship between DII and some CVD risk factors. However, results across studies are inconsistent, making consensus challenging. Future studies in larger well-powered samples, with longer intervention periods and more diverse inflammatory biomarkers, are needed to ascertain whether a decrease in DII mediated by a MedDiet intervention is effective in reducing inflammation and CVD risk factors. | 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. and J.S.C.; supervision, K.J.M.; funding acquisition, K.J.M. All authors have read and agreed to the published version of the manuscript. | 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.Tertiles of dietary inflammatory index (adjusted for energy) and adiposity at baseline: (Tertiles of Dietary Inflammatory Index (adjusted for energy) and HDL cholesterol at baseline. * Tertiles of dietary inflammatory index (adjusted for energy) and systolic blood pressure at baseline; * Comparison of dietary inflammatory index score between Mediterranean diet and habitual diet over time.Showing statistical analysis by linear mixed effects model with a diet x time interaction comparing MedDiet and HabDiet across 3 time points. Mean values ± SEM. DII, dietary inflammatory index; E-DII, dietary inflammatory index adjusted for energy; MedDiet, Mediterranean diet; HabDiet, habitual diet; 95%CI, 95% confidence interval.Baseline values for MedLey outcome variables per DII tertile.Baseline values for MedLey outcome variables presented as mean and SEM with 95% confidence intervals when grouped into tertiles of DII | 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 acquisition. HBV status was the main outcome categorized using Hepatitis B surface antigen (HBsAg) and total Hepatitis B core antibody (HBcAb). Baseline characteristics potentially associated with never being infected were analyzed using logistic regression. | 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% and 3.4% were negative and positive for HBsAg respectively. The prevalence on HBV infection was 3.9% among males and 2.8% among females while prevalence by site was: Entebbe (4.9%); Kampala (4.1%) and Nairobi (0.3%). The highest HBV prevalence was found among participants aged 25-29-years (5.2%), those with primary level education (4.5%), and those in informal low risk jobs (6.5%). Considering 1265 participants with complete data on HBsAg and HBcAb-Total, HBV status was never infected (67.9%), past infection (28.5%), chronic infection (3.2%) and acute infection (0.5%). Of 859 who were never infected, 685 (79.7%) were tested for anti-HBs titers of whom 60 (8.8%) had titers >10IU/L (immune due to vaccination). The odds of never being HBV infected were lower among older individuals 25–29 years (AOR 0.51; 95%CI 0.36–0.71) and ≥30 years (AOR 0.35; 95% CI 0.25–0.49). The odds were higher among participants with informal high-risk jobs from Kampala (AOR 2.21; 95% CI 1.41–3.47) and Nairobi (AOR 2.61; 95% CI 1.72–4.00) compared to those from Entebbe. | 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 infection. HIV prevention intervention trials are a platform to identify individuals that need HBV vaccination. | 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 a cross-sectional survey among female sex workers (FSWs), men who have sex with men (MSM) and injection drug users (IDUs) in South Africa (prevalence similar across KPs) [Simulated HIV vaccine efficacy trials (SiVETs) using licensed Hepatitis B vaccine (ENGERIX-B™ GlaxoSmithKline Biologicals Rixensart, Belgium and EUVAX by SANOFI Pasteur) to approximate the vaccination schedules and conditions of an HIV vaccine trial have been conducted among KPs in SSA. The SiVETs reported on vaccination completion and retention [ | 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 Uganda sites in Entebbe and Kampala enrolled fisher folk and FSWs respectively while the Kenya site in Nairobi enrolled FSWs and MSM. The study teams worked closely with community leadership, peer leaders, and existing Community Advisory Boards (CABs) to identify and educate potential participants and ensure that recruitment procedures were acceptable. Study information was given through community information seminars, on-site participant meetings and during the CAB meetings. The Kampala and Nairobi study teams enrolled from pre-existing cohorts and the Entebbe study team enrolled from fishing communities. Interested participants were told about eligibility criteria (e.g., at risk of HIV acquisition) and invited for study screening. | 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 December 2015 to July 2017 until a cohort of 250 SiVET participants (80 from the island, 170 from the mainland) was enrolled. | 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 up a cohort of FSWs including emancipated/ mature minors according to national guidelines [ | 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 and volunteers referred to KAVI-ICR until a cohort of 250 SiVET volunteers was enrolled. | 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 of clinics in Nairobi (Nairobi). As part of the screening process for all the SiVET studies, volunteers gave a blood sample to test for Hepatitis B infection and HIV, and a urine sample for pregnancy. Volunteers were not eligible for the SiVET if they were found to be pregnant or living with HIV. | 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 measured IgM antibodies to core protein (HBcAb (IgM)) while all sites measured antibodies to surface protein (anti-HBs) in at least a subset of volunteers who were also screened for an immunology sub-study. This sub-study aimed to assess how the pre-existing immune status affected responses to Hepatitis B vaccination and therefore needed individuals who had never been exposed to Hepatitis B either through vaccination or prior infection. The assays used to test serum samples for Hepatitis B at the 3 sites are shown below ( | 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 Ethics and Research Committee (P137/03/2015). We obtained written informed consent from all participants before any study procedures. | PMC10351693 | |
Results | PMC10351693 | |||
Socio-demographic characteristics of participants screened for SiVET studies in Kenya and Uganda (2014–2017) | As shown in | PMC10351693 |
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