The relationship between hormonal contraceptive method use and sexually transmitted infections is not well understood. Studies that implement routine screening for STIs among different contraceptive users, such as the ASPIRE HIV-1 prevention trial, can be useful for identifying potential risk factors of STIs. However, the complex nature of non-random data can lead to challenges in estimation of associations for potential risk factors. In particular, if screening for the disease is not random (i. e. it is driven by symptoms or other clinical indicators), estimates of association can suffer from bias, often referred to as informative sampling bias. Time-varying predictors and potential stratification variables can further contribute to difficulty in obtaining unbiased estimates. In this paper, we estimate the association between time- varying contraceptive use and Sexually transmitted infections acquisition, in the presence of informative sampling, by extending the work Buzkova (2010). We use a two-step procedure to jointly model the non-random screening process and sexually transmitted infection risk. In the first step, inverse intensity rate ratios (IIRR) weights are estimated. In the second step, a weighted proportional rate model is fit to estimate the IIRR weighted hazard ratio. We apply the method to evaluate the relationship between hormonal contraception and risk of sexually transmitted infections among women participating in a biomedical HIV-1 prevention trial. We compare our results using the proposed weighted method to those generated using conventional approaches that do not account for potential informative sampling bias or do not use the full potential of the data. Using the IIRR weighted approach we found depot medroxyprogesterone acetate users have a significantly decreased hazard of Trichomonas vaginalis acquisition compared to IUD users (hazard ratio: 0.44, 95% CI: (0.25, 0.83)), which is consistent with the literature. We did not find significant increased or decreased hazard of other STIs for hormonal contraceptive users compared to non-hormonal IUD users.
Progressive muscle relaxation (PMR) and autogenic training (AT) are effective relaxation techniques to reduce depressive symptoms. However, no studies on their effectiveness have been conducted among people living with HIV and depressive symptoms. The primary aim of this pilot study was to assess the feasibility and acceptability of PMR and AT interventions among people living with HIV who have depressive symptoms. A secondary aim was to assess the potential effectiveness of these interventions on depressive symptoms and quality of life.
This study was a three-arm pilot randomized control trial with mixed methods. Participants were randomized to PMR, AT, or a control group (CG), with four assessments (baseline, and at one, three, and six months). The PMR and AT interventions consisted of six 1 h sessions of individual training over 12 weeks, plus home practice. Recruitment, attrition, and completion rates were calculated. Depressive symptoms and quality of life were assessed at all times. Participants' perceptions of the interventions were collected in semi-structured interviews.
Following the screening, 54/63 people met the inclusion criteria, and 42/54 were randomly allocated to the PMR group (n=14), AT group (n=14), and CG (n=14). Six participants (43%; 95% CI 18–71%) in the PMR group and 10 (71%; 95% CI 42–92%) in the AT group completed the intervention. Participants reported better emotion management and improvements in depressive symptoms and quality of life.
The pilot study suggests that a randomized trial to test the effectiveness of these interventions is feasible.
This paper is establishing the relationship between the spreading dynamics of the Covid-19 pandemic in Morocco and the efficiency of the measures and actions taken by public authorities to contain it. The main objective is to predict the evolution of the COVID-19 pandemic in Morocco and to estimate the time needed for its disappearance.
For these reasons, we have highlighted the role of mathematical models in understanding the transmission chain of this virus as well as its future evolution. Then we used the SIR epidemiological model, which proves to be well suited to address this issue. It shows that identification of the key parameters of this pandemic, such as the probability of transmission, should help to adequately explain its behaviour and make it easier to predict its progress.
As a result, the measures and actions taken by the public authorities in Morocco allowed to record lower number of virus reproduction than many countries.
So, in the case of Morocco, we were able to predict that the Covid-19 pandemic should disappear in a shorter time and without registering a larger number of infected individuals compared to other countries.
Women with chronic pelvic pain represent a heterogeneous group, and it is suggested that the existence of sub-groups can explain varying results and inconclusiveness in clinical trials. Some predictors of treatment outcome are suggested, but the evidence is limited. The primary aim of this study was to explore if selected pre-treatment characteristics of the participants in a recently conducted randomized controlled trial were associated with treatment outcome.
In this study secondary analysis of data collected in a randomized trial were conducted. The participants were women with chronic pelvic pain randomized to two different physical therapy treatments. Analyses in this study were performed for the whole group as a cohort. The primary outcome measure was change in pain intensity from baseline to 12 months, measured with the numeric rating scale (0–10). The women were asked to rate their mean pelvic pain intensity during the last 7 days. Based on previous research and on available variables from the randomized controlled trial four potential predictive factors were derived from the baseline data and assessed one by one in a linear regression model, adjusted for age and treatment group. The variables with strongest association (p < 0.10) with the primary outcome were further included in a multivariable linear regression model with backward selection, adjusted for age and treatment group.
Fifty women (mean age 38.1, SD = 12.2) were included in the analysis. For these women the mean change in pain intensity was −1.2 points (95% CI −1.8 to −0.7) from baseline to 12 months. The multivariable regression model showed that pelvic pain duration of 6 years or more was associated with less decrease in pain intensity with a regression coefficient of 1.3 (95% CI 0.3–2.4). Baseline pain intensity was associated with higher pain reduction after PT treatment with a regression coefficient per SD increase in baseline pain of −0.6 (95% CI −1.1 to −0.1). None of the women with main pain site other places than in the pelvis reported any pain reduction after physical therapy treatment, but due to the small numbers the predictor was not included in the regression analysis.
We identified that pelvic pain duration of 6 years or more was associated with less pain reduction, and that higher baseline pain intensity was associated with higher pain reduction after physical therapy treatment in this sample of women with chronic pelvic pain. For the variable main pain site other places than the pelvis the results are unsure due to small numbers.
Based on our finding of long pain duration as a negative predictor for pain reduction, we emphasize that early intervention is important. Many of the participants in our RCT reported pelvic surgeries or other treatments prior to referral for PT, and we suggest that referral to a non-invasive intervention such as PT should be considered at an earlier stage. In order to tailor interventions to the individual women’s needs, thorough baseline assessments, preferably in a multidisciplinary setting, should be performed.
The randomized controlled trial (RCT) is currently facing several challenges, one of these being that the placebo response appears to be increasing in RCTs, thereby making it difficult to demonstrate an effect of potentially new treatments over placebo. This problem has primarily been approached by predicting the magnitude of the placebo response via stable factors, such as demographic variables, and/or by developing complex designs aimed at reducing the placebo response in the hope that it will improve the test of the active treatment. Yet, the success of this approach has so far been limited.
A new approach toward improving the RCT is put forward based on placebo and nocebo mechanism studies, i.e. studies that investigate the mechanisms underlying placebo analgesia and nocebo hyperalgesia. In a series of meta-analyses the magnitude of placebo and nocebo effects were determined. Experimental studies across nociplastic and neuropathic pain conditions and across pharmacological and acupuncture treatments investigated psychological and neurobiological mechanisms underlying these effects. The obtained results were used to make approximations of expectations to see if that could predict the placebo response in RCTs and function as a new way of tapping into the placebo component of treatment effects.
The magnitude of placebo and nocebo effects is large and highly variable. Placebo effects exist across chronic pain conditions with varying degrees of known etiology as well as across pharmacological and non-pharmacological treatments. Patients’ perception of the treatment, the verbal suggestions given for pain relief, and the patients’ expectations toward pain relief contribute to the magnitude of the placebo effect and to pain relief following placebo interventions. Also, unintentional unblinding and patients’ perception of a treatment markedly influence the treatment outcome. By making approximations of expectations toward treatment effects it was possible to predict the magnitude of the placebo response in RCTs.
Conclusions and implications
The new approach of tapping into or directly asking patients about their perception and expectations toward a treatment, along with the account of the natural history of pain, has the potential to improve the information that can be obtained from RCTs. Thus, by interfacing insights from placebo and nocebo mechanism studies, it may be possible to enhance the information that can be obtained from RCTs and to account for a large part of the variability in the placebo component of the overall treatment effect. This approach has the potential to improve the scientific evaluation of treatments, as well as to illustrate how the effect of treatments can be optimized in clinical practice, which is the crux of evidence-based medicine.
Open radical nephrectomy and inferior vena cava exploration through a roof top incision involves significant peri-operative morbidity including severe postoperative pain. Although thoracic epidural analgesia provides excellent pain relief, recent trends suggest search for effective alternatives. Systemic morphine is often used as an alternative analgesic technique. However, it does not provide dynamic analgesia and can often impede recovery in patients undergoing major surgery on the abdomen. The authors present the first report of a novel analgesic regimen in this cohort with good outcomes.
Five patients undergoing open radical nephrectomy and inferior vena cava exploration received erector spinae plane infusion and intra thecal opioid analgesia at a tertiary care university teaching hospital. Outcomes included dynamic analgesia, length of hospital stay and complications
Five adult patients undergoing major upper abdominal surgery, who refused thoracic epidural analgesia, received erector spinae plane infusion and intrathecal opioid analgesia. Patients reported effective dynamic analgesia, minimal use of rescue analgesia, early ambulation and enhanced recovery.
The novel regimen that avoids both epidural analgesia and systemic morphine can be an option in enabling enhanced recovery in this cohort.
The ACR1990 criteria of fibromyalgia (FM) have been criticized due to poor reliability of tender points counting (TPC), inconsistent definitions of the widespread pain, and by not considering other symptoms than pain in the FM phenotype. Therefore, several newer self-report measures for FM criteria have emerged. The aim of this study was to translate the fibromyalgia survey questionnaire (FSQ) to Norwegian and validate both the 2011 and the 2016 fibromyalgia survey diagnostic criteria (FSDC) against the ACR1990 criteria.
One hundred and twenty chronic pain patients formerly diagnosed with fibromyalgia according to the ACR1990 criteria, and 62 controls not diagnosed or where fibromyalgia was not suspected, were enrolled in this study. All responded to a Norwegian version of the FSQ. Also, they had a clinical examination according to ACR1990 fibromyalgia criteria including a counting of significant tender points with an algometer (TPC). The FSQ with the Widespread Pain Index (WPI) and Symptom Severity scale (SSS) subscales, Fibromyalgia Severity (FS) sum score, was examined for correlations with the fibromyalgia impact questionnaire (FIQ) and TPCs. Face-validity, internal consistence, test-retest reliability and construct validity with convergent and divergent approaches were examined and a Receiver Operating Characteristics (ROC) analysis was performed.
The internal consistency of FS measured by Cronbach’s alfa was good (=0.904). The test-retest reliability measures using intra class correlation were respectable for the FS, including WPI and SSS subscales (0.86, 0.84 and 0.87). FS, WPI and SSS correlated significantly with FIQ (0.74, 0.59 and 0.85) and TPC indicating an adequate construct, convergent validity. The medians of FS, WPI and SSS in the fibromyalgia-group were significantly different from the non-fibromyalgia-group indicating good construct, divergent validity. Using the 2011 and 2016 FSDC vs. ACR 1990 as a reference, sensitivity, specificity, positive likelihood ratio (LR +) and negative likelihood ratio (LR−) were identified. The accuracy rate for both 2011 and 2016 FSDC were respectable (84%). ROC analysis using FS revealed a very good Area Under the Curve (AUC) = 0.860.
The current study revealed that the Norwegian versions of FSQ is a valid tool for assessment of fibromyalgia according to the 2011 and 2016 (FSDC).