Intervening on women's health for rural young breast cancer survivors: A study protocol.

INTRODUCTION: From diagnosis to post-treatment, many young breast cancer survivors (YBCS) experience infertility, limited contraception choices, concern about pregnancy safety, and menopausal symptoms. Clinical guidelines recommend oncofertility care (counseling and/or clinical services that meet fertility, contraception, pregnancy health and/or menopausal symptom management needs) throughout the cancer care continuum. However, significant oncofertility care gaps exist in rural, community oncology settings. MATERIALS AND METHODS: We describe the design of an interrupted time series, effectiveness-implementation hybrid clinical trial that evaluates a multi-component intervention to improve YBCS engagement in oncofertility care. The intervention is comprised of 1) oncology clinic-based oncofertility needs screen; 2) a women's health survivorship care plan in Spanish and English; 3) remote patient navigation; and 4) telehealth oncofertility consultation. During the pre-intervention period (12 months), usual care will be delivered. During the intervention period (15 months), the multi-component intervention will be implemented at two rural oncology clinics with largely Latina, Spanish-speaking populations. The primary outcome of YBCS (n = 135) engagement in oncofertility care will be collected from medical record review. We will also collect validated patient-reported outcomes. Informed by the Exploration Preparation Implementation Sustainment (EPIS) implementation science framework, we will integrate qualitative and quantitative data to explore whether and how the intervention was effective, acceptable, appropriate, and delivered with fidelity. DISCUSSION: Our overall goal is to speed implementation of a scalable oncofertility care intervention for YBCS in underserved areas to reduce disparities and improve reproductive health and quality of life. TRIAL REGISTRATION: Clinicaltrials.gov Identifier: NCT05414812.

Comparison of amitriptyline supplemented with pregabalin, pregabalin supplemented with amitriptyline, and duloxetine supplemented with pregabalin for the treatment of diabetic peripheral neuropathic pain (OPTION-DM): a multicentre, double-blind, randomised crossover trial.

BACKGROUND: Diabetic peripheral neuropathic pain (DPNP) is common and often distressing. Most guidelines recommend amitriptyline, duloxetine, pregabalin, or gabapentin as initial analgesic treatment for DPNP, but there is little comparative evidence on which one is best or whether they should be combined. We aimed to assess the efficacy and tolerability of different combinations of first-line drugs for treatment of DPNP. METHODS: OPTION-DM was a multicentre, randomised, double-blind, crossover trial in patients with DPNP with mean daily pain numerical rating scale (NRS) of 4 or higher (scale is 0-10) from 13 UK centres. Participants were randomly assigned (1:1:1:1:1:1), with a predetermined randomisation schedule stratified by site using permuted blocks of size six or 12, to receive one of six ordered sequences of the three treatment pathways: amitriptyline supplemented with pregabalin (A-P), pregabalin supplemented with amitriptyline (P-A), and duloxetine supplemented with pregabalin (D-P), each pathway lasting 16 weeks. Monotherapy was given for 6 weeks and was supplemented with the combination medication if there was suboptimal pain relief (NRS >3), reflecting current clinical practice. Both treatments were titrated towards maximum tolerated dose (75 mg per day for amitriptyline, 120 mg per day for duloxetine, and 600 mg per day for pregabalin). The primary outcome was the difference in 7-day average daily pain during the final week of each pathway. This trial is registered with ISRCTN, ISRCTN17545443. FINDINGS: Between Nov 14, 2017, and July 29, 2019, 252 patients were screened, 140 patients were randomly assigned, and 130 started a treatment pathway (with 84 completing at least two pathways) and were analysed for the primary outcome. The 7-day average NRS scores at week 16 decreased from a mean 6·6 (SD 1·5) at baseline to 3·3 (1·8) at week 16 in all three pathways. The mean difference was -0·1 (98·3% CI -0·5 to 0·3) for D-P versus A-P, -0·1 (-0·5 to 0·3) for P-A versus A-P, and 0·0 (-0·4 to 0·4) for P-A versus D-P, and thus not significant. Mean NRS reduction in patients on combination therapy was greater than in those who remained on monotherapy (1·0 [SD 1·3] vs 0·2 [1·5]). Adverse events were predictable for the monotherapies: we observed a significant increase in dizziness in the P-A pathway, nausea in the D-P pathway, and dry mouth in the A-P pathway. INTERPRETATION: To our knowledge, this was the largest and longest ever, head-to-head, crossover neuropathic pain trial. We showed that all three treatment pathways and monotherapies had similar analgesic efficacy. Combination treatment was well tolerated and led to improved pain relief in patients with suboptimal pain control with a monotherapy. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment programme.

Changing how we risk-categorise in Ramadan: Does the IDF-DAR scoring system achieve the requirements for people with diabetes internationally?

The IDF-DAR guidance was most recently updated this year. The most notable change is the moving to a scoring system from a tabulated risk categorization to determine and classify the risk of harm from fasting derived from an online survey. This change may be appealing and is welcomed. However, such a system and the methodology underpinning it is not without limitations. This commentary highlights some of these limitations and the associated limited safe options available to individuals with diabetes desiring to fast during Ramadan. Overlooked clinical considerations that deserve formal recognition include the role of technology (aspects relating to glucose monitoring and/or insulin delivery) and previous experience of safe Ramadan fasting. Further, duration of fast (which can almost double in temperate regions from winter to summer) needs greater emphasis. We also advocate separate scoring systems for people with type 1 diabetes and complex type 2 diabetes. The guidance acknowledges fasting is an individual's decision, however the general message needs to be more person-centred and currently only presents a binary approach to fasting - all or nothing choices. We propose and discuss addition options including, trial fasting of voluntary fasts, starting the fast and terminating due to health and/or safety, intermittent fasting and winter fasting.

Ramadan and Diabetes: A Narrative Review and Practice Update.

Fasting in the Islamic month of Ramadan is obligatory for all sane, healthy adult Muslims. The length of the day varies significantly in temperate regions-typically lasting ≥ 18 h during peak summer in the UK. The synodic nature of the Islamic calendar means that Ramadan migrates across all four seasons over an approximately 33-year cycle. Despite valid exemptions, there is an intense desire to fast during this month, even among those who are considered to be at high risk, including many individuals with diabetes mellitus. In this review we explore the current scientific and clinical evidence on fasting in patients with diabetes mellitus, focussing on type 2 diabetes mellitus and type 1 diabetes mellitus, with brief reviews on pregnancy, pancreatic diabetes, bariatric surgery, the elderly population and current practice guidelines. We also make recommendations on the management of diabetes patients during the month of Ramadan. Many patients admit to a do-it-yourself approach to diabetes mellitus management during Ramadan, largely due to an under-appreciation of the risks and implications of the rigors of fasting on their health. Part of the issue may also lie with a healthcare professional's perceived inability to grasp the religious sensitivities of Muslims in relation to disease management. Thus, the pre-Ramadan assessment is crucial to ensure a safe Ramadan experience. Diabetes patients can be risk-stratified from low, medium to high or very high risk during the pre-Ramadan assessment and counselled accordingly. Those who are assessed to be at high to very high risk are advised not to fast. The current COVID-19 pandemic upgrades those in the high-risk category to very high risk; hence a significant number of diabetes patients may fall under the penumbra of the 'not to fast' advisory. We recognize that fasting is a personal choice and if a person chooses to fast despite advice to the contrary, he/she should be adequately supported and monitored closely during Ramadan and for a brief period thereafter. Current advancements in insulin delivery and glucose monitoring technologies are useful adjuncts to strategies for supporting type 1 diabetes patients considered to be high risk as well as 'high-risk' type 2 patients manage their diabetes during Ramadan. Although there is a lack of formal trial data, there is sufficient evidence across the different classes of therapeutic hypoglycaemic agents in terms of safety and efficacy to enable informed decision-making and provide a breadth of therapeutic options for the patient and the healthcare professional, even if the professional advice is to abstain. Thus, Ramadan provides an excellent opportunity for patient engagement to discuss important aspects of management, to improve control in the short term during Ramadan and to help the observants understand that the metabolic gains achieved during Ramadan are also sustainable in the other months of the year by maintaining a dietary and behavioural discipline. The application of this understanding can potentially prevent long-term complications. ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (10.1007/s13300-020-00886-y) contains supplementary material, which is available to authorized users.

Ramadan and Diabetes: A Narrative Review and Practice Update.

Fasting in the Islamic month of Ramadan is obligatory for all sane, healthy adult Muslims. The length of the day varies significantly in temperate regions-typically lasting ≥ 18 h during peak summer in the UK. The synodic nature of the Islamic calendar means that Ramadan migrates across all four seasons over an approximately 33-year cycle. Despite valid exemptions, there is an intense desire to fast during this month, even among those who are considered to be at high risk, including many individuals with diabetes mellitus. In this review we explore the current scientific and clinical evidence on fasting in patients with diabetes mellitus, focussing on type 2 diabetes mellitus and type 1 diabetes mellitus, with brief reviews on pregnancy, pancreatic diabetes, bariatric surgery, the elderly population and current practice guidelines. We also make recommendations on the management of diabetes patients during the month of Ramadan. Many patients admit to a do-it-yourself approach to diabetes mellitus management during Ramadan, largely due to an under-appreciation of the risks and implications of the rigors of fasting on their health. Part of the issue may also lie with a healthcare professional's perceived inability to grasp the religious sensitivities of Muslims in relation to disease management. Thus, the pre-Ramadan assessment is crucial to ensure a safe Ramadan experience. Diabetes patients can be risk-stratified from low, medium to high or very high risk during the pre-Ramadan assessment and counselled accordingly. Those who are assessed to be at high to very high risk are advised not to fast. The current COVID-19 pandemic upgrades those in the high-risk category to very high risk; hence a significant number of diabetes patients may fall under the penumbra of the 'not to fast' advisory. We recognize that fasting is a personal choice and if a person chooses to fast despite advice to the contrary, he/she should be adequately supported and monitored closely during Ramadan and for a brief period thereafter. Current advancements in insulin delivery and glucose monitoring technologies are useful adjuncts to strategies for supporting type 1 diabetes patients considered to be high risk as well as 'high-risk' type 2 patients manage their diabetes during Ramadan. Although there is a lack of formal trial data, there is sufficient evidence across the different classes of therapeutic hypoglycaemic agents in terms of safety and efficacy to enable informed decision-making and provide a breadth of therapeutic options for the patient and the healthcare professional, even if the professional advice is to abstain. Thus, Ramadan provides an excellent opportunity for patient engagement to discuss important aspects of management, to improve control in the short term during Ramadan and to help the observants understand that the metabolic gains achieved during Ramadan are also sustainable in the other months of the year by maintaining a dietary and behavioural discipline. The application of this understanding can potentially prevent long-term complications.

Be wary of a mature adult, who presents with a parent.

The importance of interviewing a patient alone cannot be overemphasised, especially when a mature adult patient presents with a parent. We present the case of a 47-year-old man who was seen in the outpatient clinic with his mother, as his general practitioner (GP) was concerned whether he had a pheochromocytoma. The GP had arranged a CT scan of the abdomen, to investigate for an abdominal cause for oedematous legs. This had picked a benign growth in the right adrenal gland. A 24-hour urinary normetanephrine level checked was raised. Further tests and regular monitoring showed persistently raised levels of catecholamines to the point that adrenalectomy was being considered. He was always accompanied by his mother except on the clinic visit, when he admitted to taking amphetamine. Urinary catecholamine levels normalised, after he stopped taking it.

Hemodynamic and pulmonary changes after drainage of significant pleural effusions in critically ill, mechanically ventilated surgical patients.

PURPOSE: Our purpose was to study the effects of drainage of significant pleural effusions in mechanically ventilated patients in a surgical intensive care unit. METHODS: Twenty-two ventilated patients in the surgical intensive care unit of a tertiary care center over a 12-month period who developed a pleural effusion large enough to require drainage were studied prospectively. All patients underwent serial portable chest radiography in the upright or semiupright position; the radiographs were reviewed by a radiology attending. Pleural effusions were classified as small, moderate, or large. Moderate or larger effusions were drained using an 8- to 12-Fr pigtail catheter inserted at the bedside under ultrasound guidance. Hemodynamic and pulmonary parameters were collected before and after the fluid was drained. Parameters studied included those outlined in the physiologic profile and included measured and calculated physiologic variables, arterial blood gas measurements, and Svo2 measurements. Ventilator settings before and after were also recorded. RESULTS: Average initial pleural effusion drainage was 1,262 +/- 762 mL (range, 300-2,980 mL). Nine of the 22 patients had effusions drained from both the right and left chest. Blood pressure, systemic vascular resistance, Po2, Pco2, Svo2, Fio2, peak airway pressure, and spontaneous volume did not change significantly. Pulmonary capillary wedge pressure decreased (17.4 +/- 6.0 before, 13.6 +/- 4.4 after; p < 0.01), central venous pressure decreased (14.2 +/- 5.2 before, 11.5 +/- 4.4 after; p < 0.02), and pulmonary arteriovenous shunt decreased (26.7 +/- 15.1 before, 21.0 +/- 7.8 after; p < 0.04). Oxygen delivery increased (579.7 +/- 214.7 before, 662.8 +/- 263.3 after; p < 0.01) and oxygen consumption increased (146.3 +/- 61.6 before, 175.2 +/- 73.8 after; p < 0.01). Respiratory rate also decreased (19.4 +/- 6.5 before, 15.5 +/- 6.3 after; p < 0.05). There were no complications from the placement of the pigtail catheters. CONCLUSION: Drainage of pleural effusions results in increased oxygen delivery and oxygen consumption coinciding with a decrease in pulmonary capillary wedge pressure. The pulmonary arteriovenous shunt decreased, implying an increase in functional residual capacity and improved oxygenation. Further study is needed to determine whether these changes lead to an improved patient outcome (i.e., reduction in length of stay, ventilator days, or mortality).