1.52 to 4.50). Test-retest reliability was moderate (total score intraclass correlation coefficient, ICC(2,1)=0.69). CONCLUSIONS The MPNS-36 demonstrated acceptable reliability and validity. It is the first measure to capture perceived menstrual hygiene and may be useful across a range of study designs. Future research should explore the validity and suitability of the measure across contexts and populations. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.INTRODUCTION Because of the lack of prehospital protocols to rule out a non-ST-segment elevation acute coronary syndrome (NSTE-ACS), patients with chest pain are often transferred to the emergency department (ED) for thorough evaluation. However, in low-risk patients, an ACS is rarely found, resulting in unnecessary healthcare consumption. Using the HEART (History, ECG, Age, Risk factors and Troponin) score, low-risk patients are easily identified. When a point-of-care (POC) troponin measurement is included in the HEART score, an ACS can adequately be ruled out in low-risk patients in the prehospital setting. However, it remains unclear whether a prehospital rule-out strategy using the HEART score and a POC troponin measurement in patients with suspected NSTE-ACS is cost-effective. METHODS AND ANALYSIS The ARTICA trial is a randomised trial in which the primary objective is to investigate the cost-effectiveness after 30 days of an early rule-out strategy for low-risk patients suspected of a NSTE-ACS, using a modified HEART score including a POC troponin T measurement. Patients are included by ambulance paramedics and 11 randomised for (1) presentation at the ED (control group) or (2) POC troponin T measurement (intervention group) and transfer of the care to the general practitioner in case of a low troponin T value. In total, 866 patients will be included. Follow-up will be performed after 30 days, 6 months and 12 months. ETHICS AND DISSEMINATION This trial has been accepted by the Medical Research Ethics Committee region Arnhem-Nijmegen. The results of this trial will be disseminated in one main paper and in additional papers with subgroup analyses. TRIAL REGISTRATION NUMBER Netherlands Trial Register (NL7148). © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVE To explore the perspectives of general practitioners (GPs) concerning the risk of opioid misuse in people with cancer and pain and related clinical considerations. DESIGN A qualitative approach using semistructured telephone interviews. Analysis used an integrative approach. SETTING Primary care. PARTICIPANTS Australian GPs with experience of prescribing opioids for people with cancer and pain. RESULTS Twenty-two GPs participated, and three themes emerged. Theme 1 (Misuse is not the main problem) contextualised misuse as a relatively minor concern compared with pain control and toxicity, and highlighted underlying systemic factors, including limitations in continuity of care and doctor expertise. Theme 2 ('A different mindset' for cancer pain) captured participants' relative comfort in prescribing opioids for pain in cancer versus non-cancer contexts, and acknowledgement that compassion and greater perceived community acceptance were driving factors, in addition to scientific support for mechanisms ontext of new treatments for metastatic disease. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVE To examine the relationship between visit-to-visit systolic blood pressure (SBP) variability and patient-reported outcome measure of disability in multiple sclerosis (MS) patients. DESIGN A retrospective cohort study of individuals with MS who completed a patient-determined disease steps (PDDS) scale between 2011 and 2015 at an MS specialty clinic. PARTICIPANTS Individuals with MS for whom both a completed PDDS scale and ≥3 SBP measures within the prior 12 months of the survey were available. MAIN OUTCOME MEASURE Participants were grouped into three classes of disability (no or mild (PDDS 0-1), moderate (2-3), severe (4-7)). SBP variability was calculated as within-subject SD using all SBP measures taken during the past 12 months. SBP variability was analysed by Tertile groups. RESULTS Ninety-two subjects were included in this analysis. Mean PDDS score was 2.22±1.89. Compared with subjects in Tertile 1 (lowest variability), the odds of being in a higher disability group was 3.5 times higher (OR=3.48; 95% CI 1.08 to 11.25; p=0.037) in Tertile 2 and 5.2 times higher (OR=5.19; 95% CI 1.53 to 17.61; p=0.008) in Tertile 3 (highest variability), independent of mean SBP, age, sex, race/ethnicity, body mass index and comorbidities (p for trend=0.008). Mean PDDS scores were 1.52±1.18 in Tertile 1, 2.73±1.02 in Tertile 2 and 2.42±0.89 in Tertile 3 after adjusting for the same covariates. CONCLUSIONS Our results show a significant gradient relationship between SBP variability and MS-related disability. More research is needed to determine the underlying pathophysiological relationship between SBP variability and MS disability progression. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVES After regulatory approval, drug companies, public funding agencies and academic researchers often pursue trials aimed at extending the uses of a new drug by testing it in new non-approved indications. Patient burden and clinical impact of such research are not well understood. DESIGN AND SETTING We conducted a retrospective cohort study of postapproval clinical trials launched within 5 years after the drug's first approval, testing anticancer drugs in monotherapy in indications that were first pursued after a drug's first Food and Drug Administration (FDA) license, for all 12 anticancer drugs approved between 2005 and 2007. FDA, Medline and Embase search date 2019 February 12. PRIMARY AND SECONDARY OUTCOME MEASURES Our primary objective was to measure burden and clinical impact for patients enrolling in these trials. Each trial was sorted into a 'trajectory' defined by the drug and cancer indication. The risk was operationalised by proportions of grade 3-4 severe adverse events and deaths. The clinrm priority setting in research and provide a basis for calibrating expectations when considering enrolment in label-extending trials. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.OBJECTIVE To identify factors influencing the provision, utilisation and sustainability of midwifery units (MUs) in England. DESIGN Case studies, using individual interviews and focus groups, in six National Health Service (NHS) Trust maternity services in England. SETTING AND PARTICIPANTS NHS maternity services in different geographical areas of England Maternity care staff and service users from six NHS Trusts two Trusts where more than 20% of all women gave birth in MUs, two Trusts where less than 10% of all women gave birth in MUs and two Trusts without MUs. Obstetric, midwifery and neonatal clinical leaders, managers, service user representatives and commissioners were individually interviewed (n=57). Twenty-six focus groups were undertaken with midwives (n=60) and service users (n=52). MAIN OUTCOME MEASURES Factors influencing MU use. FINDINGS The study findings identify several barriers to the uptake of MUs. Within a context of a history of obstetric-led provision and lack of decision-maker awareness obe restricted. https://www.selleckchem.com/products/a-674563.html © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.INTRODUCTION Neuropathic low back-related leg pain (LBLP) can be a challenge to healthcare providers to diagnose and treat. Accurate diagnosis of neuropathic pain is fundamental to ensure appropriate intervention is given. However, to date there is no gold standard to diagnose neuropathic LBLP. A Delphi study will therefore be conducted to obtain an expert-derived consensus list of clinical indicators to identify a neuropathic component to LBLP. METHODS/ANALYSIS Included participants will be considered experts within the field as measured against a predefined eligibility criterion. Through an iterative multistage process, participants will rate their agreement with a list of clinical indicators and suggest any missing clinical indicators during each round. Agreement will be measured using a 5-point Likert scale. Descriptive statistics will be used to measure agreement; median, IQR and percentage of agreement. A priori consensus criteria will be defined for each round. Data analysis at the end of round three will enable a list of clinical indicators to be derived. ETHICS AND DISSEMINATION Ethical approval was gained from the University of Birmingham (ERN_19-1142). On completion of the study, findings will be disseminated in a peer-reviewed journal and presented at relevant conferences. © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.BACKGROUND More than two decades of conflict and natural disasters in Somalia have resulted in one of the longest running humanitarian crises in the world. Nutrition data have been collected over the years despite challenges to inform programmatic action. This paper explores malnutrition and morbidity trends in Somalia during the last decade, disaggregated by geographical zone and livelihood system. METHODS We used data from 291 cross-sectional surveys conducted in children aged 6-59 months between 2007 and 2016 in Somalia. Wasting, morbidity and stunting prevalences over time were analysed by geographic area, livelihood system and season. Logistic regressions were used to test trends. RESULTS The wasting trends show a striking peak in 2011, more marked in southern and central Somalia and coinciding with the famine declaration. The trend declines slightly thereafter although not consistently across all zones and livelihoods, and it raises again in 2016 especially among internally displaced persons (IDPs). Stu) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.INTRODUCTION To accelerate progress to reach the sustainable development goals for ending preventable maternal, newborn and child deaths, it is critical that both the public and private health service delivery systems invest in increasing coverage of interventions to sustainably deliver quality care for mothers, newborns and children at scale. Although various approaches have been successful in high-income countries, little is known about how to effectively engage and sustain private sector involvement in delivering quality care in low-income and middle-income countries. Our systematic review will examine private sector implementation of quality care for maternal, newborn and child health (MNCH) and the impact of this care. This protocol details our intended methodological and analytical approaches, based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) reporting guideline for protocols. METHODS AND ANALYSIS Following the PRISMA approach, this systematic review will include quantitative, qualitative and mixed-methods studies addressing the provision of quality MNCH care by private sector providers.