Menstrual Practice Needs Scale short form (MPNS-SF) and rapid (MPNS-R): development in Khulna, Bangladesh, and validation in cross-sectional surveys from Bangladesh and Uganda

Objectives
Develop and validate short and rapid forms of the 36-item Menstrual Practice Needs Scale (MPNS-36).

Design
Item reduction prioritised content validity and was informed by cognitive interviews with schoolgirls in Bangladesh, performance of scale items in past research and stakeholder feedback. The original MPNS-36 was revalidated, and short and rapid forms tested in a cross-sectional survey. This was followed by further tests of dimensionality, internal consistency and validity in multiple cross-sectional surveys.

Setting and participants
Short form (MPNS-SF) and rapid form (MPNS-R) measures were developed in a survey of 313 menstruating girls (mean age=13.51) in Khulna, Bangladesh. They were further tested in the baseline survey of the Adolescent Menstrual Experiences and Health Cohort, in Khulna, Bangladesh (891 menstruating girls, mean age=12.40); and the dataset from the MPNS-36 development in Soroti, Uganda (538 menstruating girls, mean age=14.49).

Results
The 18-item short form reflects the six original subscales, with the four core subscales demonstrating good fit in all three samples (Khulna pilot: root mean square error of approximation (RMSEA)=0.064, 90% CI 0.043 to 0.084, Comparative Fit Index (CFI)=0.94, Tucker-Lewis Index (TLI)=0.92. Cohort baseline: RMSEA=0.050, 90% CI 0.039 to 0.062, CFI=0.96, TLI=0.95. Uganda: RMSEA=0.039, 90% CI 0.028 to 0.050, CFI=0.95, TLI=0.94). The 9-item rapid form captures diverse needs. A two-factor structure was the most appropriate but fell short of adequate fit (Khulna pilot: RMSEA=0.092, 90% CI 0.000 to 0.158, CFI=0.93, TLI=0.89). Hypothesised associations between the MPNS scores and other constructs were comparable between the MPNS-36 and MPNS-SF in all populations, and replicated, with attenuation, in the MPNS-R. Internal consistency remained acceptable.

Conclusions
The MPNS-SF offers a reliable and valid measure of adolescent girls’ menstrual hygiene experience while reducing participant burden, to support implementation and improve measurement in menstrual health research. The MPNS-R provides a brief measure with poorer structural validity, suited to short surveys and including menstrual health within broader research topics.

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Luglio 2024

Pain Scores as Secondary Outcomes—Opioid Reduction Studies

To the Editor In their article describing the effects of telehealth mindfulness on opioid use reduction, Cooperman and colleagues include pain as a secondary outcome. Pain is assessed at baseline, 8 weeks, and 16 weeks using the Brief Pain Inventory (BPI), and twice daily throughout using Ecological Momentary Assessment (EMA). At baseline, BPI pain scores are 5.1 and 5.2 (intervention and comparison, respectively); initial EMA pain scores are 5.79 and 5.19, respectively. This potentially suggests either a pain spike in the intervention group or excessive variance. After treatment, EMA pain scores are 5.17 and 4.97 respectively; it appears that the treatment-induced pain decrease has brought treatment-group pain levels back to just above baseline. Interpretation is limited as final BPI values and EMA time course data are not provided. Although the provided protocol does not include specific timeline details, it is not uncommon for randomization to follow baseline testing; typically, this promotes baseline outcome similarity. If, as we postulate, randomization occurred after BPI baseline and before initial EMAs, then assignment to intervention, with frequent therapy and video-supervised drug testing, may have prompted elevated EMA pain scores. Perhaps treatment assignment had an impact, but clarifying data are not provided. A minor concern is that the study protocol proposed that BPI analysis would average all 4 elements at baseline, 8 weeks, and 16 weeks; instead, the article included just 1 BPI component and only at baseline. A second important concern: EMA pain score modeling uses a normal distribution term to represent intraindividual pain score variability. Normal distributions do not adequately capture variation in pain scores, especially those obtained outside controlled laboratory settings where pain score variation typically exceeds that of normal distributions. Increasingly, zero-inflated distributions are used to represent the intrinsic variability of pain scores. The authors use zero-inflated distributions to model substance use; inclusion of such to represent pain could be preferrable. No mention is made of any correction for multiple comparisons; this is a minor concern but potentially impactful. Finally, the authors indicate in the discussion that the decrease in treatment group EMA pain scores meets Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) criteria for significant change, but this is not correct. The referenced IMMPACT criteria specify that pain score changes of 15% to 20% are considered minimally significant. A change of 11%, which may actually represent a return to prerandomization baseline, and a secondary outcome at that, is not minimally significant.

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Luglio 2024

Examining Safer Opioid Supply Policies

To the Editor We felt compelled to raise concerns regarding the design and conclusions of the recent cohort study by Nguyen et al in JAMA Internal Medicine because Slaunwhite et al authored another recent population-based cohort study in a separate journal using individual-level data that reached different conclusions. Although the ecological design used by Nguyen et al can be useful, this design is prone to well-known biases regarding attribution. In this case, misclassification in exposure (fentanyl and oxycodone, 2 of 4 drug classes that were not included in the Risk Mitigation Guidance) and outcome (hospitalizations only, excluding emergency department visits and other health care contacts for people who overdose) exacerbate these biases.

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Luglio 2024

Examining Safer Opioid Supply Policies

To the Editor Nguyen and colleagues investigated outcomes of the British Columbia Safer Opioid Supply policy 2 years after implementation and found a significant increase in opioid-related overdose hospitalizations. Given that opioid use disorders and harm reduction policies have multifactorial health and societal implications, we argue that it is still too early to evaluate the full effect of this policy on opioid-related health outcomes.

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Luglio 2024

Endocrine Adverse Effects of Long-Term Opioid Use

Opioid-induced endocrinopathies are underrecognized in current practice. Chronic opioid use (more than 1 month), whether prescribed for chronic pain or as treatment for opioid use disorder (OUD), disrupts the hypothalamic-pituitary-adrenal and hypothalamic-pituitary-gonadal axes, potentially leading to hypogonadism, hypoadrenalism, hyperprolactinemia, and osteoporosis (through mechanisms independent of hypogonadism). The prevalence of hypogonadism in patients taking long-term opioids is estimated to be approximately 50%. The prevalence of hypoadrenalism is less well defined. The extent and severity of these endocrinopathies may vary based on opioid duration, dose, route, and type. For example, long-acting opioids are more strongly associated with endocrinopathies than short-acting opioids, and partial opioid agonists such as buprenorphine may cause less hypothalamic-pituitary-gonadal suppression than full agonists.

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Luglio 2024

Examining Safer Opioid Supply Policies—Reply

In Reply We express our gratitude to our correspondents for their thoughtful comments on our recent cohort study. One key consideration raised was whether the results of our study may be confounded by the disruptions of the COVID-19 pandemic, particularly the COVID-19–related closures or restricted operation of supervised consumption sites in British Columbia, Canada, early in 2020. Although we cannot entirely rule out the possibility of such confounding, the sensitivity analyses showed that policy effects were even larger from July 2021 to March 2022 when these supervised consumption site visitations had already returned to prepandemic levels.

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Luglio 2024

Opioid-Induced Adrenal Insufficiency

This case report describes a woman in her 40s with opioid use disorder receiving methadone who was admitted for extended antibiotic treatment for methicillin-resistant Staphylococcus aureus bacteremia and was subesequently diagnosed with opioid-induced adrenal insufficiency.

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Luglio 2024

Examining Safer Opioid Supply Policies

To the Editor In their recent article, Nguyen et al provided a timely investigation into opioid-related health outcomes associated with British Columbia’s Prescribed Safer Supply policy. We identified important limitations to this analysis of population-level government data warranting further discussion.

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Luglio 2024

Pain Scores as Secondary Outcomes—Opioid Reduction Studies—Reply

In Reply In the response from Hogans to our study describing the effects of telehealth Mindfulness-Oriented Recovery Enhancement (MORE), they note that baseline Brief Pain Inventory (BPI) scores differed from the initial ecological momentary assessment (EMA) rating of pain and question whether this discrepancy relates to either a pain spike in the intervention group or excessive variance. It is unlikely that any potential increase in pain was due to MORE, given that MORE significantly reduced pain in our pilot study in the same population of patients with pain and opioid use disorder receiving methadone treatment, and MORE produced significant reductions in pain relative to active control conditions across 10 effect sizes from randomized clinical trials (RCTs) in a recent meta-analysis (standardized mean change = 0.60; 95% CI, −0.83 to −0.37; P 

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Luglio 2024

New entity of adult ultra-short coeliac disease: the first international cohort and case-control study

Background
Ultra-short coeliac disease (USCD) is defined as villous atrophy only present in the duodenal bulb (D1) with concurrent positive coeliac serology. We present the first, multicentre, international study of patients with USCD.

Methods
Patients with USCD were identified from 10 tertiary hospitals (6 from Europe, 2 from Asia, 1 from North America and 1 from Australasia) and compared with age-matched and sex-matched patients with conventional coeliac disease.

Findings
Patients with USCD (n=137, median age 27 years, IQR 21–43 years; 73% female) were younger than those with conventional coeliac disease (27 vs 38 years, respectively, p

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Giugno 2024

Opioid-free anaesthesia with dexmedetomidine and lidocaine versus remifentanil-based anaesthesia in cardiac surgery: study protocol of a French randomised, multicentre and single-blinded OFACS trial

Introduction
Intraoperative opioids have been used for decades to reduce negative responses to nociception. However, opioids may have several, and sometimes serious, adverse effects. Cardiac surgery exposes patients to a high risk of postoperative complications, some of which are common to those caused by opioids: acute respiratory failure, postoperative cognitive dysfunction, postoperative ileus (POI) or death. An opioid-free anaesthesia (OFA) strategy, based on the use of dexmedetomidine and lidocaine, may limit these adverse effects, but no randomised trials on this issue have been published in cardiac surgery.
We hypothesised that OFA versus opioid-based anaesthesia (OBA) may reduce the incidence of major opioid-related complications after cardiac surgery.

Methods and analysis
Multicentre, randomised, parallel and single-blinded clinical trial in four cardiac surgical centres in France, including 268 patients scheduled for coronary artery bypass grafting under cardiac bypass, with or without aortic valve replacement. Patients will be randomised to either a control OBA protocol using remifentanil or an OFA protocol using dexmedetomidine/lidocaine. The primary composite endpoint is the occurrence of at least one of the following: (1) postoperative cognitive disorder evaluated by the Confusion Assessment Method for the Intensive Care Unit test, (2) POI, (3) acute respiratory distress or (4) death within the first 48 postoperative hours. Secondary endpoints are postoperative pain, morphine consumption, nausea–vomiting, shock, acute kidney injury, atrioventricular block, pneumonia and length of hospital stay.

Ethics and dissemination
This trial has been approved by an independent ethics committee (Comité de Protection des Personnes Ouest III–Angers on 23 February 2021). Results will be submitted in international journals for peer reviewing.

Trial registration number
NCT04940689, EudraCT 2020-002126-90.

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Giugno 2024

Characterising incident opioid use among incident users of prescription sedative hypnotics: A national cohort study

Objective
To evaluate co-prescribing of sedatives hypnotics and opioids.

Design
Retrospective study evaluating the association of patient characteristics and comorbidities with coprescribing.

Setting and participants
Using the national Merative MarketScan Database between 2005 and 2018, we identified patients who received an incident sedative prescription with or without subsequent, incident opioid prescriptions within a year of the sedative prescription in the USA.

Outcome measures
Coprescription of sedative-hypnotics and opioids.

Results
A total of 2 632 622 patients (mean (SD) age, 43.2 (12.34) years; 1 297 356 (62.5%) female) received incident prescriptions for sedatives over the course of the study period. The largest proportion of sedative prescribing included benzodiazepines (71.1%); however, z-drugs (19.9%) and barbiturates (9%) were also common. About 557 845 (21.2%) patients with incident sedatives also received incident opioid prescriptions. About 59.2% of these coprescribed patients received opioids coprescription on the same day. Multivariate logistic regression findings showed that individuals with a comorbidity index score of 1, 2 or ≥3 (aOR 1.19 (95% CI 1.17 to 1.21), 1.17 (95% C 1.14 to 1.19) and 1.25 (95% C 1.2 to 1.31)) and substance use disorder (1.21 (95% C 1.19 to 1.23)) were more likely to be coprescribed opioids and sedatives. The likelihood of receiving both opioid and sedative prescriptions was lower for female patients (aOR 0.93; 95% CI 0.92 to 0.94), and those receiving a barbiturate (aOR 0.3; 95% CI 0.29 to 0.31) or z-drugs (aOR 0.67; 95% CI 0.66 to 0.68) prescriptions at the index date.

Conclusions
Coprescription of sedatives with opioids was associated with the presence of comorbidities and substance use disorder, gender and types of sedatives prescribed at the index date. Additionally, more than half of the coprescribing occurred on the same day which warrants further evaluation of current prescribing and dispensing best practice guidelines.

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Maggio 2024