Natalie Edelman

Oral vs intravenous paracetamol for lower third molar extractions under general anaesthesia: is oral administration inferior?

BACKGROUND Paracetamol formulations provide effective analgesia after surgery [Duggan ST, Scott LJ. Intravenous paracetamol (acetominophen). Drugs 2009; 69: 101-13; Toms L, McQuay HJ, Derry S, Moore RA. Single dose oral paracetamol (acetaminophen) for postoperative pain in adults. Cochrane Database Syst Rev 2008: CD004602]. I.V. paracetamol is superior to oral for pain rescue (Jarde O, Boccard E. Parenteral versus oral route increases paracetamol efficacy. Clin Drug Invest 1997; 14: 474-81). By randomized, double-blinded trial, we aimed to determine whether preoperative oral paracetamol provides inferior postoperative analgesia to preoperative i.v. paracetamol. METHODS One hundred and thirty participants received either oral paracetamol and i.v. placebo (Group OP), or oral placebo and i.v. paracetamol (Perfalgan™) (Group IP). Oral preparations were given at least 45 min before surgery; i.v. preparations after induction of anaesthesia. Pain was assessed by a 100 mm visual analogue scale (VAS) 1 h from the end of surgery. Rescue analgesia was given on request. RESULTS A total of 128 patients completed the study. There were no significant differences in baseline characteristics or intraoperative variables between the groups. The study was designed to reveal whether OP is inferior to IP, with an inferiority margin of 20%. The number of patients reporting satisfactory analgesia at 1 h with VAS ≤ 30 mm were 15 (OP) and 17 (IP), respectively. The secondary outcome measure of the mean (standard deviation) VAS (mm) for the whole of each group was 52 (22) for OP and 47 (22) for IP. Analysis of confidence intervals indicates that oral paracetamol is not inferior to i.v. paracetamol. The median survival (90% CI) to rescue analgesia request was 54.3 (51.2-57.4) min in Group OP and 57.3 (55.4-59.2) min in Group IP; there was no significant difference in this measure. CONCLUSIONS In this study of lower third molar extraction, oral paracetamol is not inferior to i.v. for postoperative analgesia. ISRCTN Registration http://www.controlled-trials.com/ISRCTN77607163.

Evaluation of public involvement in research: time for a major re-think?:

The way that public involvement in research has been evaluated as a complex intervention has derailed the development of an evidence base. Two alternative approaches are available for constructing and evaluating patient involvement, each of which requires us to revisit the purposes and values that underpin it in each stage of the research process.

Understanding barriers to sexual health service access among substance-misusing women on the South East coast of England

Objectives Evidence suggests substance-misusing women (SMW) experience disproportionate sexual health morbidity and poor uptake of interventions including contraception and cervical screening, yet there has been little investigation of sexual health service access issues for this population. Methods Twenty women with problem drug use in Hastings in South East England, UK participated in a one-to-one interview with a researcher to explore experiences and beliefs surrounding access to a range of sexual health service interventions. Transcripts were open-coded and themes were elicited and organised concerning barriers to access. Results Drug-use lifestyles, trauma and low self-worth framed the lives of SMW and hindered sexual health service access through: depleted practical and emotional resources to enable attendance; high perceived emotional cost of discussing sexual histories, and coping with tests and unfavourable results; and low anticipated value of sexual health interventions due to low perception and minimisation of risk and perceived incompatibility between drug use and sexual well-being. Conclusions A range of practical, social and emotional barriers to sexual health service access exist for this population, presenting a context from within which use of services may come at considerable personal cost to SMW. Interventions addressing anticipated stigma and emotional, hygiene and fiscal concerns are warranted for this population.

Can a six-week exercise intervention improve gross motor function for non-ambulant children with cerebral palsy? A pilot randomized controlled trial

Objective: To determine the effect of a six-week exercise intervention on gross motor function for non-ambulant children with cerebral palsy. Design: A parallel arm randomized controlled trial. Setting: Four special schools. Participants: Thirty-five children aged 8–17 with bilateral cerebral palsy; Gross Motor Function Classification System levels IV–V. Method: Participants were randomly allocated to a static bike group, a treadmill group or control group. Participants in the bike and treadmill groups received exercise training sessions, three times weekly for six weeks. The control group received their usual care. Blinded assessments were performed at baseline and six weeks and followed up at 12 and 18 weeks. Outcome measures: Gross Motor Function Measures GMFM-66, GMFM-88D and GMFM-88E. Results: At six weeks significant differences were found in GMFM-88D scores between the bike group and the control group, and the treadmill group and the control group (P < 0.05). The mean change (SD) in GMFM-88D score was 5.9 (6.8) for the bike group; 3.7 (4.4) for the treadmill group and 0.5 (1.9) for the control group. No significant differences were found for GMFM-66 or GMFM-88E scores between the bike group and control group, or the treadmill group and control group, although trends of improvement were observed for both exercise groups. The improvements observed declined during the follow-up period. Conclusion: This study provides preliminary evidence that exercising on a bike or treadmill may provide short-term improvements in gross motor function for non-ambulant children with cerebral palsy. This needs to be tested in a large-scale randomized trial.

Can psychosocial and socio-demographic questions help identify sexual risk among heterosexually-active women of reproductive age? Evidence from Britain’s third National Survey of Sexual Attitudes and Lifestyles (Natsal-3)

BackgroundContraceptive advice and supply (CAS) and sexually transmitted infection (STI) testing are increasingly provided in primary care. Most risk assessment tools are based on sexual risk behaviours and socio-demographics, for use online or in specialist services. Combining socio-demographic and psychosocial questions (e.g. religious belief and formative experience) may generate an acceptable tool for targeting women in primary care who would benefit from intervention. We aimed to identify psychosocial and socio-demographic factors associated with reporting key sexual risk behaviours among women in the British general population.MethodsWe undertook complex survey analysis of data from 4911 hetero-sexually active women aged 16–44 years, who participated in Britain’s third National Survey of Sexual Attitudes and Lifestyles (Natsal-3), a national probability sample survey undertaken 2010–2012. We used multivariable regression to examine associations between the available psychosocial and socio-demographic variables in Natsal-3 and reports of three key sexual behaviours: a) 2+ partners in the last year (2PP); b) non-use of condoms with 2+ partners in the last year (2PPNC); c) non-use of condoms at first sex with most recent sexual partner (FSNC). We adjusted for key socio-demographic factors: age, ethnicity and socio-economic status (measured by housing tenure).ResultsWeekly binge drinking (6+ units on one occasion), and first sex before age 16 were each positively associated with all three sexual behaviours after adjustment. Current relationship status, reporting drug use (ever), younger age and living in rented accommodation were also associated with 2+ partners and 2 + partners without condoms after adjustment. Currently being a smoker, older age and respondent ethnicity were associated with FSNC after adjustment for all other variables. Current smoking status, treatment for depression (last year), and living at home with both parents until the age of 14 were each associated with one or more of the behaviours.ConclusionsReported weekly binge drinking, early sexual debut, and age group may help target STI testing and/or CAS among women. Further research is needed to examine the proportion of sexual risk explained by these factors, the acceptability of these questions to women in primary care and the need to customise them for community and other settings.

Sexual health risks and health-seeking behaviours among substance-misusing women

AIMS To report on a survey of sexual health service needs among substance-misusing women attending a substance misuse service. BACKGROUND Substance-misusing women carry a disproportionate burden of sexual ill health, yet the range and frequency of their sexual health risks, morbidities and service engagement are poorly understood. DESIGN A cross-sectional survey of a convenience sample of substance-misusing women attending a substance misuse service. METHODS From 4 April 2010-17 September 2010, substance-misusing women in Hastings & Ore, UK, were invited to complete a paper questionnaire addressing: drug use; cervical cytology, sexually transmitted infection and HIV screening history; pregnancy history, perceived pregnancy risk and contraceptive advice and supply; sexual activity and assault. Of 91 respondents, 77 attended local drug treatment services - results comprise analysis of this sub-sample. RESULTS The study sample was characterized by long-term opioid and crack cocaine use. Of 53% sexually active in the previous 4 weeks, 66% perceived they had experienced sexual intercourse that could lead to pregnancy during that time. Fifty-five per cent had been forced to have sex against their will during their lifetime. High rates of sexually transmitted infections, pregnancy termination, miscarriage and abnormal cervical cytology were reported. CONCLUSIONS Findings indicate the need to recognize the breadth of elevated sexual health risks and morbidities experienced by substance-misusing women with long-term opioid/crack use, including those not identifying as intravenous drug users. Poor recall of drop-in and appointment times, reluctance to disclose substance misuse and likelihood of previous sexual assault present significant challenges to nurses, who must take a sensitive, opportunistic approach to referral and provision of sexual health interventions to substance-misusing women.

The effect of intra-operative passive movement therapy on non-surgical site pain after breast reconstructive surgery: a preliminary study†

Pain distant to an operative site is under‐reported but sometimes more severe than pain from the surgical site. Intra‐operative passive movement could possibly reduce this pain. This preliminary study was designed to assess the practicalities of conducting a randomised controlled trial of this therapy in anaesthetised patients. The study design was pragmatic. Forty‐two patients undergoing breast reconstruction were randomly assigned to receive either intra‐operative passive movement or standard care. Twenty‐four hours after surgery, median (IQR [range]) morphine consumption was 33 (11–42 [0–176]) mg in the passive movement group compared with 74 (15–118 [0–238]) mg with standard care (p = 0.126), while participants reported median (IQR [range]) visual analogue scores in areas distant from the surgical site of 0 (0–4 [0–34]) mm in the passive movement group compared with 10 (2–30 [0–57]) mm in those receiving standard care (p = 0.002). A full trial of intra‐operative passive movement therapy to reduce postoperative is feasible and warranted.

Targeting sexual health services in primary care: A systematic review of the psychosocial correlates of adverse sexual health outcomes reported in probability surveys of women of reproductive age

BACKGROUND Women using primary care vary in need for sexually transmitted infections (STIs) testing and contraception. Psychosocial correlates of these needs may be useful for targeting services. We undertook a systematic review to identify psychosocial correlates of STI acquisition, unplanned pregnancy (UP), abortion and risky sexual behaviours in general population samples of women of reproductive age. METHODS We searched bibliographic databases for probability surveys of women aged 16-44 years in the European Union, USA, Canada, Australia, UK or New Zealand undertaken January 1994-January 2014. RESULTS Eleven papers were included. Unplanned pregnancy was associated with smoking, depression, being single and sexual debut <16 years. Abortion was associated with lack of closeness to parents, leaving home at an early age, and relationship break-up. Multiple partnerships were associated with intensity of marijuana and alcohol use, and smoking. STI diagnosis was associated with relationship break-up and younger partners. Non-use of contraception was associated with smoking, obesity, relationship status, sedentary lifestyles, fatalistic pregnancy attitudes and lower alcohol use. Condom non-use was higher (at first sex) with partners 5+years older and lower (at last sex) in less stable partnerships. CONCLUSION Psychosocial variables, particularly relationship status and smoking, may help identify women in primary care for STI testing and contraception advice and supply.

Deriving a clinical prediction rule to target sexual healthcare to women attending British General Practices

Some women attending General Practices (GPs) are at higher risk of unintended pregnancy (RUIP) and sexually transmitted infections (STI) than others. A clinical prediction rule (CPR) may help target resources using psychosocial questions as an acceptable, effective means of assessment. The aim was to derive a CPR that discriminates women who would benefit from sexual health discussion and intervention. Participants were recruited to a cross-sectional survey from six GPs in a city in South-East England in 2016. On arrival, female patients aged 16-44 years were invited to complete a questionnaire that addressed psychosocial factors, and the following self-reported outcomes: 2+ sexual partners in the last year (2PP) and RUIP. For each sexual risk, psychosocial questions were retained from logistic regression modelling which best discriminated women at risk using the C-statistic. Sensitivity and specificity were established in consultation with GP staff. The final sample comprised N = 1238 women. 2PP was predicted by 11 questions including age, binge-drinking weekly, ever having a partner who insulted you often, current smoking, and not cohabiting (C-statistic = 0.83, sensitivity = 73% and specificity = 77%). RUIP was predicted by 5 questions including sexual debut <16 years, and emergency contraception use in the last 6 months (C-statistic = 0.70, sensitivity = 69% and specificity = 57%). 2PP was better discriminated than RUIP but neither to a clinically-useful degree. The finding that different psychosocial factors predicted each outcome has implications for prevention strategies. Further research should investigate causal links between psychosocial factors and sexual risk.

Researching Sexual Healthcare for Women with Problematic Drug Use: Returning to Ethical Principles in Study Processes

This chapter illustrates how privileging of the ethical principle of non-maleficence may exclude the most vulnerable from research participation. ‘Patient and public involvement’ is presented as a powerful tool for developing ways of enabling participation, and the notion of ‘lay women’ as distinct from ‘researcher women’ is discussed. These issues are articulated through the example of a mixed-methods study in the UK. Women with problematic drug use were identified as study collaborators and consulted in meetings and via postal review of documents. The chapter also highlights ways of addressing ethical concerns that arise after approval and describes ethical subtleties involved in respecting the rights of participants and study collaborators to speak about painful subjects, whilst ensuring their well-being and maintaining boundaries.