388Investigating the utility of the customised fetal growth chart: a pragmatic randomised controlled trial

Abstract Background To determine if the routine use of a customised fetal growth chart, when compared to a standard growth chart, reduces the risk of adverse pregnancy outcome through increased detection of adverse growth. Methods A double-blind, single centre, randomised controlled trial was conducted. All women with a singleton pregnancy receiving routine antenatal care through hospital clinics were included and randomised to either a standard growth chart (SC) or a customised growth chart (CC). Serial measurements of symphyseal fundal height (SFH) were plotted onto the chart in the electronic clinical record; pre-programmed alerts notified the clinician when growth or size required review. The primary outcome measure was a composite perinatal morbidity/mortality outcome. Results 3993 women were recruited; 45.4% nulliparous; 50.0% Caucasian, 17.8% Asian; 34.9% were overweight/obese prior to pregnancy; average 30 (SD 5.5) years old. The median (IQR) number of growth alerts was 2 (0-3) for both groups (p = 0.378); there was no difference in the total number of ultrasounds per pregnancy (median [IQR] 3 [2-4] for both groups, p = 0.266). There was no significant difference in primary composite outcome (CC 6.4%, SC 7.5%, p = 0.171) or individual components, apart from stillbirth (CC n = 1 0.05%, SC n = 8 0.4%, p = 0.039). Conclusions Use of a CC resulted in no difference in primary outcome, number of growth alerts or number of ultrasounds. Key messages In a large, pragmatic RCT use of a CC in conjunction with serial SFH measurements may infer some benefit over a SC, particularly in relation to stillbirth.

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A double-blind, randomised, controlled trial of protein supplementation to enhance exercise capacity in COPD during pulmonary rehabilitation: a pilot study

ERJ Open Research ◽

10.1183/23120541.00077-2021 ◽

2021 ◽

pp. 00077-2021

Author(s):

Abdulelah M. Aldhahir ◽

Yousef S. Aldabayan ◽

Jaber S. Alqahtani ◽

Heidi A. Ridsdale ◽

Colette Smith ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Exercise Capacity ◽

Pulmonary Rehabilitation ◽

Controlled Trial ◽

Protein Supplementation ◽

High Protein ◽

Double Blind ◽

Meaningful Improvement ◽

Significant Difference ◽

Randomised Controlled

BackgroundPulmonary rehabilitation (PR) is a cost-effective management strategy in chronic obstructive pulmonary disease (COPD) which improves exercise performance and health-related quality of life. Nutritional supplementation may counter malnutrition and enhance PR outcomes but rigorous evidence is absent. We aimed to investigate the effect of high protein-supplementation (Fortisip Compact Protein, FCP) during PR on exercise capacity.MethodsA double-blind randomised controlled trial comparing FCP with preOp (a carbohydrate control supplement) in COPD patients participating in a PR programme. Participants consumed the supplement twice a day during PR and attended twice-weekly PR sessions, with pre- and post-PR measurements including the incremental shuttle walk test (ISWT) at 6-weeks as the primary outcome. Participants’ experience using supplements was assessed.ResultsSixty-eight patients were recruited; (FCP: 36 and control: 32). The trial was stopped early due to COVID-19. Although statistical significance was not reached, there was the suggestion of a clinically meaningful difference in ISWT at 6 weeks favouring the intervention group (intervention: 342 m±149; n=22 versus control: 305 m±148; n=22, p=0.1). Individuals who achieved an improvement in ISWT had larger mid-thigh circumference at baseline (responder: 62 cm±4 versus non-responder: 55 cm±6; p=0.006). 79% were satisfied with the taste and 43% would continue taking the FCP.ConclusionAlthough the data did not demonstrate a statistically significant difference in ISWT, high protein supplementation in COPD during PR may result in a clinically meaningful improvement in exercise capacity and was acceptable to patients. Large, adequately powered studies are justified.

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O04 Clinical and cost-effectiveness of ultrasound-guided intra-articular corticosteroid and local anaesthetic injection for hip OA: a randomised controlled trial (HIT)

Rheumatology ◽

10.1093/rheumatology/keaa110.003 ◽

2020 ◽

Vol 59 (Supplement_2) ◽

Author(s):

Zoe Paskins ◽

Kieran Bromley ◽

Martyn Lewis ◽

Gemma Hughes ◽

Emily Hughes ◽

...

Keyword(s):

Cost Effectiveness ◽

Randomised Controlled Trial ◽

Pain Intensity ◽

Primary Outcome ◽

Controlled Trial ◽

Hip Pain ◽

Ultrasound Guided ◽

Life Years ◽

Significant Difference ◽

Randomised Controlled

Abstract Background Evidence of the effectiveness of intra-articular corticosteroid injection for hip osteoarthritis (OA) is limited. The HIT trial compared the clinical and cost-effectiveness of an ultrasound-guided intra-articular hip injection (USGI) of 40mg triamcinolone acetonide and 4ml 1% lidocaine hydrochloride combined with best current treatment (BCT) with (i) BCT alone (primary objective) and (ii) an USGI of 5ml 1% lidocaine only combined with BCT (EudraCT:2014-003412-37). Methods This was a pragmatic, three-parallel arm, single-blind, randomised controlled trial in adults with moderate-severe painful hip OA recruited from community musculoskeletal services and primary care. Participants were randomised equally to: (1) BCT alone, (2) BCT plus USGI triamcinolone/lidocaine, or (3) BCT plus USGI lidocaine only. Outcomes were collected postally at 2 weeks, 2, 4 and 6 months. The primary outcome was self-reported current hip pain intensity (0-10 numeric rating scale (NRS)) over 6 months (repeated measures analysis). Secondary outcomes included function (WOMAC), and, for cost-utility analysis, general health (EQ-5D-5L) and healthcare utilisation. 204 participants were required to detect a minimum difference of 1 point in mean pain NRS score between arms (1) and (2) with 80% power (5% two-tailed significance level, 15% loss to follow-up). Analysis was by intention-to-treat. Results 199 participants were recruited (43% male, mean age 63 years), 67 to arm (1) and 66 each to arms (2) and (3). Primary outcome completion rates were 95% at 2 weeks, 94% at 2 months, 90% at 4 months, and 89% at 6 months. Greater mean improvement in hip pain intensity (0-10 NRS) over 6 months was seen with BCT plus USGI triamcinolone/lidocaine compared with BCT alone: -1.43 (95%CI -2.15,-0.72). Greater mean improvement in pain intensity was seen at 2 weeks (-3.17; -4.06,-2.28) and 2 months (-1.81;-2.71,-0.92), but not at 4 (-0.86;-1.78,0.05) or 6 months (0.12; -0.80,1.04). Participants treated with BCT plus USGI triamcinolone/lidocaine compared with BCT alone had greater mean improvement in function (WOMAC-F -5.47;(-9.41,-1.53)) over 6 months. There was no statistically significant difference in hip pain intensity over 6 months between BCT plus USGI triamcinolone/lidocaine compared with BCT plus USGI lidocaine (-0.52;-1.21,0.18). There was one possible treatment-related serious adverse event: a participant with no signs of infection at randomisation died from endocarditis four months after USGI triamcinolone/lidocaine. BCT plus USGI triamcinolone/lidocaine was less costly (mean cost difference per participant £-161.59) and associated with significantly higher quality-adjusted life-years (QALYs) than BCT only over 6 months (mean difference 0.0477 (0.0257,0.0699). Conclusion USGI triamcinolone/lidocaine plus BCT leads to greater improvements in pain and function over 6 months in adults with hip OA than BCT alone, and was highly cost-effective. There was no significant difference in hip pain intensity between the groups receiving USGI triamcinolone/lidocaine and USGI lidocaine only, raising the possibility of a degree of placebo effect. Disclosures Z. Paskins None. K. Bromley None. M. Lewis None. G. Hughes None. E. Hughes None. A. Cherrington None. A. Hall None. M. Holden None. R. Oppong None. J. Kigozi None. K. Stevenson None. A. Menon None. P. Roberts None. G. Peat None. C. Jinks None. N.E. Foster None. C.D. Mallen None. E. Roddy None.

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Efficacy of nature-based therapy for individuals with stress-related illnesses: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2018.2 ◽

2018 ◽

Vol 213 (1) ◽

pp. 404-411 ◽

Cited By ~ 12

Author(s):

Ulrika Karlsson Stigsdotter ◽

Sus Sola Corazon ◽

Ulrik Sidenius ◽

Patrik Karlsson Nyed ◽

Helmer Bøving Larsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Well Being ◽

Behavioural Therapy ◽

Primary Outcome Measure ◽

Secondary Outcome ◽

Significant Difference ◽

Increasing Demand ◽

Randomised Controlled

BackgroundStress-related illnesses are a major threat to public health, and there is increasing demand for validated treatments.AimsTo test the efficacy of nature-based therapy (NBT) for patients with stress-related illnesses.MethodRandomised controlled trial (ClinicalTrials.gov ID NCT01849718) comparing Nacadia® NBT (NNBT) with the cognitive–behavioural therapy known as Specialised Treatment for Severe Bodily Distress Syndromes (STreSS). In total, 84 participants were randomly allocated to one of the two treatments. The primary outcome measure was the mean aggregate score on the Psychological General Well-Being Index (PGWBI).ResultsBoth treatments resulted in a significant increase in the PGWBI (primary outcome) and a decrease in burnout (the Shirom–Melamed Burnout Questionnaire, secondary outcome), which were both sustained 12 months later. No significant difference in efficacy was found between NNBT and STreSS for primary outcome and secondary outcomes.ConclusionsThe study showed no statistical evidence of a difference between NNBT and STreSS for treating patients with stress-related illnesses.Declaration of interestNone.

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Droperidolv. haloperidol for sedation of aggressive behaviour in acute mental health: Randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.bp.114.150227 ◽

2015 ◽

Vol 206 (3) ◽

pp. 223-228 ◽

Cited By ~ 27

Author(s):

Leonie Calver ◽

Vincent Drinkwater ◽

Rahul Gupta ◽

Colin B. Page ◽

Geoffrey K. Isbister

Keyword(s):

Mental Health ◽

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Behavioural Disturbance ◽

Significant Difference ◽

Psychiatric Units ◽

Secondary Outcomes ◽

Randomised Controlled ◽

Effective Sedation

BackgroundAgitation and aggression are significant problems in acute psychiatric units. There is little consensus on which drug is most effective and safest for sedation of these patients.AimsTo compare the effectiveness and safety of haloperidolv. droperidol for patients with agitation and aggression.MethodIn a masked, randomised controlled trial (ACTRN12611000565943) intramuscular droperidol (10 mg) was compared with intramuscular haloperidol (10 mg) for adult patients with acute behavioural disturbance in a psychiatric intensive care unit. The primary outcome was time to sedation within 120 min. Secondary outcomes were use of additional sedation, adverse events and staff injuries.ResultsFrom 584 patients, 110 were randomised to haloperidol and 118 to droperidol. Effective sedation occurred in 210 (92%) patients within 120 min. There was no significant difference in median time to sedation: 20 min (interquartile range 15–30, range 10–75) for haloperidolv. 25 min (IQR 15–30, range 10–115) for droperidol (P= 0.89). Additional sedation was used more often with haloperidol (13%v. 5%,P= 0.06), but adverse effects were less common with haloperidol (1%v. 5%,P= 0.12). There were 8 staff injuries.ConclusionsBoth haloperidol and droperidol were effective for sedation of patients with acute behavioural disturbance.

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Perioperative haemodynamic therapy for major gastrointestinal surgery: the effect of a Bayesian approach to interpreting the findings of a randomised controlled trial

BMJ Open ◽

10.1136/bmjopen-2018-024256 ◽

2019 ◽

Vol 9 (3) ◽

pp. e024256 ◽

Cited By ~ 7

Author(s):

Elizabeth G Ryan ◽

Ewen M Harrison ◽

Rupert M Pearse ◽

Simon Gates

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Gastrointestinal Surgery ◽

Evidence Based ◽

Bayesian Analyses ◽

Therapy Algorithm ◽

Significant Difference ◽

Randomised Controlled ◽

The Impact

ObjectiveThe traditional approach of null hypothesis testing dominates the design and analysis of randomised controlled trials. This study aimed to demonstrate how a simple Bayesian analysis could have been used to analyse the Optimisation of Perioperative Cardiovascular Management to Improve Surgical Outcome (OPTIMISE) trial to obtain more clinically interpretable results.Design, setting, participants and interventionsThe OPTIMISE trial was a pragmatic, multicentre, observer-blinded, randomised controlled trial of 734 high-risk patients undergoing major gastrointestinal surgery in 17 acute care hospitals in the UK. Patients were randomly allocated to a cardiac output-guided haemodynamic therapy algorithm for intravenous fluid and inotropic drug administration during and in the 6 hours following surgery (n=368) or to standard care (n=366). The primary outcome was a binary outcome consisting of a composite of predefined 30-day moderate or major complications and mortality.MethodsWe repeated the primary outcome analysis of the OPTIMISE trial using Bayesian statistical methods to calculate the probability that the intervention was superior, and the probability that a clinically relevant difference existed. We explored the impact of a flat prior and an evidence-based prior on our analyses.ResultsAlthough OPTIMISE was not powered to detect a statistically significant difference between the treatment arms for the observed effect size (relative risk=0.84, 95% CI 0.70 to 1.01; p=0.07), by using Bayesian analyses we were able to demonstrate that there was a 96.9% (flat prior) to 99.5% (evidence-based prior) probability that the intervention was superior to the control.ConclusionsThe use of a Bayesian analytical approach provided a different interpretation of the findings of the OPTIMISE trial (compared with the original frequentist analysis), and suggested patient benefit from the intervention. Incorporation of information from previous studies provided further evidence of a benefit from the intervention. Bayesian analyses can produce results that are more easily interpretable and relevant to clinicians and policy-makers.Trial registration numberISRCTN04386758; Post-results.

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Does addition of craving management tools in a stop smoking app improve quit rates among adult smokers? Results from BupaQuit pragmatic pilot randomised controlled trial.

10.31234/osf.io/d5kjq ◽

2019 ◽

Author(s):

Aleksandra Herbec ◽

Lion Shahab ◽

Jamie Brown ◽

Harveen Kaur Ubhi ◽

Emma Beard ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Controlled Trial ◽

Point Prevalence ◽

Management Tools ◽

Exact Test ◽

Significant Difference ◽

Continuous Abstinence ◽

Randomised Controlled

Introduction: Delivery of craving management tools (CMTs) via smartphone applications (apps) may improve smoking cessation rates, but research on such programmes remainslimited, especially in real-world settings. This study evaluated the effectiveness of adding CMTs in a cessation app (BupaQuit).Methods: The study was a two-arm pragmatic pilot parallel randomised controlled trial, comparing a fully-automated BupaQuit app with CMT with a control app version withoutCMT. A total of 425 adult UK-based daily smokers were enrolled through open online recruitment (February 2015-March 2016), with no researcher involvement, and individually randomised within the app to the intervention (n=208) or control (n=217). The primary outcome was self-reported 14-day continuous abstinence assessed at 4-week follow-up. Secondary outcomes included 6-month point-prevalence and sustained abstinence, and app usage. The primary outcome was assessed with Fisher’s exact test using intent to treat with those lost to follow-up counted as smoking. Participants were not reimbursed.Results: Re-contact rates were 50.4% at 4 weeks and 40.2% at 6 months. There was no significant difference between intervention and control arms on the primary outcome (13.5% vs 15.7%; p=0.58;RR=0.86, 95% Confidence Interval (CI)=0.54-1.36) or secondary cessation outcomes (6-month point prevalence: 14.4% vs. 17.1%, p=0.51;RR=0.85, 95%CI=0.54-1.32; 6-month sustained: 11.1% vs 13.4%, p=0.55,RR=0.83,95%CI=0.50-1.38). Bayes factors supported the null hypothesis (B[0, 0,1.0986]=.20). Usage was similar across the conditions (mean/median logins: 9.6/4 vs. 10.5/5; time spent: 401.8/202s vs. 325.8/209s).Conclusions: The addition of craving management tools did not affect cessation, and the limited engagement with the app may have contributed to this.

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REmote preconditioning for Protection Against Ischaemia–Reperfusion in renal transplantation (REPAIR): a multicentre, multinational, double-blind, factorial designed randomised controlled trial

Efficacy and Mechanism Evaluation ◽

10.3310/eme02030 ◽

2015 ◽

Vol 2 (3) ◽

pp. 1-60 ◽

Cited By ~ 15

Author(s):

Raymond MacAllister ◽

Tim Clayton ◽

Rosemary Knight ◽

Steven Robertson ◽

Jennifer Nicholas ◽

...

Keyword(s):

Renal Transplantation ◽

Randomised Controlled Trial ◽

Kidney Function ◽

Living Donor ◽

Primary Outcome ◽

Controlled Trial ◽

Double Blind ◽

Remote Preconditioning ◽

Ischaemia Reperfusion ◽

Randomised Controlled

BackgroundLong-term kidney allograft survival has remained unchanged in recent years despite immunosuppressive and surgical advances. Ischaemia–reperfusion (IR) injury sustained at transplantation contributes to kidney damage that limits allograft lifespan. Interventions to reduce IR injury may prolong graft life, delaying the need for a return to dialysis. Remote ischaemic preconditioning (RIPC), in which brief episodes of non-lethal ischaemia applied to the limb activate a systemic protective reflex against subsequent damaging IR injury, has been reported to cause cardiac, renal and neurological protection in small-scale trials.ObjectivesThe REmote preconditioning for Protection Against Ischaemia–Reperfusion in renal transplantation (REPAIR) trial investigated whether RIPC improves kidney function and other outcomes following living-donor renal transplantation.DesignMulticentre, multinational, double-blind, 2 × 2 factorial designed randomised controlled trial.SettingThirteen tertiary care hospitals in the UK, the Netherlands, Belgium and France.ParticipantsThe REPAIR trial recruited 406 live donor–recipient pairs aged ≥ 18 years. Patients on adenosine triphosphate (ATP)-sensitive potassium channel opening or blocking drugs, on ciclosporin, with a known iodine sensitivity or with ABO incompatibility or those requiring human leucocyte antigen (HLA) antibody removal therapy were excluded.InterventionsEach pair was randomised using a factorial design to one of four groups: sham RIPC, early RIPC (immediately before surgery), late RIPC (24 hours before surgery) and dual RIPC (early and late RIPC). The donor and recipient received the same intervention (active RIPC or sham RIPC) at the two time points.Main outcome measuresThe primary outcome was glomerular filtration rate (GFR) 12 months after transplantation measured by iohexol clearance. Important secondary outcomes were estimated GFR (eGFR) (using routine clinical assessment), safety, inflammatory cytokine profile and biological mechanisms.ResultsIn total, 406 donor–recipient pairs were randomised: 99 to sham RIPC, 102 to early RIPC, 103 to late RIPC and 102 to dual RIPC. Early RIPC resulted in a small but clinically important increase in iohexol GFR (ml/minute/1.73 m2) at 12 months, although the evidence is weak [58.3 vs. 55.9; adjusted difference 3.08, 95% confidence interval (CI) –0.89 to 7.04;p = 0.13], likely because of the higher than expected variability in the iohexol measurements. There was stronger evidence for a treatment effect when eGFR was used and missing values imputed (adjusted difference 3.41, 95% CI –0.21 to 7.04;p = 0.065) and when eGFR was used to assess kidney function (adjusted difference 4.98, 95% CI 1.13 to 8.29;p = 0.011). Late RIPC had no effect on renal outcomes, there was no benefit of combining early and late RIPC and RIPC had no effect on the inflammatory response to surgery. RIPC was safe and well tolerated by recipients and donors.ConclusionsRIPC is a safe intervention in living-donor transplantation. The evidence for an effect of RIPC on GFR (primary outcome) was weak, but other measures of GFR (in our secondary analysis) provided persuasive evidence of a clinically meaningful improvement in kidney function after transplantation. Future work should investigate the role of RIPC in deceased-donor kidney transplantation.Trial registrationCurrent Controlled Trials ISRCTN30083294.FundingThis project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research partnership.

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Efficacy, safety and impact on antimicrobial resistance of duration and dose of amoxicillin treatment for young children with Community-Acquired Pneumonia: a protocol for a randomIsed controlled Trial (CAP-IT)

BMJ Open ◽

10.1136/bmjopen-2019-029875 ◽

2019 ◽

Vol 9 (5) ◽

pp. e029875 ◽

Cited By ~ 1

Author(s):

Mark D Lyttle ◽

Julia A Bielicki ◽

Sam Barratt ◽

David Dunn ◽

Adam Finn ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Antimicrobial Resistance ◽

Young Children ◽

Primary Outcome ◽

Controlled Trial ◽

Treatment Strategies ◽

Community Acquired Pneumonia ◽

Primary Analysis ◽

Double Blind ◽

Randomised Controlled

IntroductionCommunity-acquired pneumonia (CAP) is a common indication for antibiotic treatment in young children. Data are limited regarding the ideal dose and duration of amoxicillin, leading to practice variation which may impact on treatment failure and antimicrobial resistance (AMR). Community-Acquired Pneumonia: a randomIsed controlled Trial (CAP-IT) aims to determine the optimal amoxicillin treatment strategies for CAP in young children in relation to efficacy and AMR.Methods and analysisThe CAP-IT trial is a multicentre, randomised, double-blind, placebo-controlled 2×2 factorial non-inferiority trial of amoxicillin dose and duration. Children are enrolled in paediatric emergency and inpatient environments, and randomised to receive amoxicillin 70–90 or 35–50 mg/kg/day for 3 or 7 days following hospital discharge. The primary outcome is systemic antibacterial treatment for respiratory tract infection (including CAP) other than trial medication up to 4 weeks after randomisation. Secondary outcomes include adverse events, severity and duration of parent-reported CAP symptoms, adherence and antibiotic resistance. The primary analysis will be by intention to treat. Assuming a 15% primary outcome event rate, 8% non-inferiority margin assessed against an upper one-sided 95% CI, 90% power and 15% loss to follow-up, 800 children will be enrolled to demonstrate non-inferiority for the primary outcome for each of duration and dose.Ethics and disseminationThe CAP-IT trial and relevant materials were approved by the National Research Ethics Service (reference: 16/LO/0831; 30 June 2016). The CAP-IT trial results will be published in peer-reviewed journals, and in a report published by the National Institute for Health Research Health Technology Assessment programme. Oral and poster presentations will be given to national and international conferences, and participating families will be notified of the results if they so wish. Key messages will be constructed in partnership with families, and social media will be used in their dissemination.Trial registration numberISRCTN76888927, EudraCT2016-000809-36.

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Effectiveness of a volunteer befriending programme for patients with schizophrenia: randomised controlled trial

The British Journal of Psychiatry ◽

10.1192/bjp.2019.42 ◽

2019 ◽

Vol 217 (3) ◽

pp. 477-483 ◽

Cited By ~ 9

Author(s):

Stefan Priebe ◽

Agnes Chevalier ◽

Thomas Hamborg ◽

Eoin Golden ◽

Michael King ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Social Isolation ◽

Primary Outcome ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Social Contacts ◽

Significant Difference ◽

Randomised Controlled

BackgroundBefriending by volunteers has the potential to reduce the frequent social isolation of patients with schizophrenia and thus improve health outcomes. However, trial-based evidence for its effectiveness is limited.AimsTo conduct a randomised controlled trial of befriending for patients with schizophrenia or related disorders.MethodPatients were randomised to a befriending programme for 1 year or to receive information about social activities only (trial registration: ISRCTN14021839). Outcomes were assessed masked to allocation at the end of the programme; at 12 months and at a 6-month follow-up. The primary outcome was daily time spent in activities (using the Time Use Survey (TUS)) with intention-to-treat analysis.ResultsA total of 124 patients were randomised (63 intervention, 61 active control) and 92 (74%) were followed up at 1 year. In the intervention group, 49 (78%) met a volunteer at least once and 31 (49%) had more than 12 meetings. At 1 year, mean TUS scores were more than three times higher in both groups with no significant difference between them (adjusted difference 8.9, 95% CI −40.7 to 58.5, P = 0.72). There were no significant differences in quality of life, symptoms or self-esteem. However, patients in the intervention group had significantly more social contacts than those in the control group at the end of the 12-month period. This difference held true at the follow-up 6 months later.ConclusionsAlthough no difference was found on the primary outcome, the findings suggest that befriending may have a lasting effect on increasing social contacts. It may be used more widely to reduce the social isolation of patients with schizophrenia.

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Pain perception with cervical tenaculum placement during intrauterine device insertion: a randomised controlled trial

BMJ Sexual & Reproductive Health ◽

10.1136/bmjsrh-2019-200376 ◽

2019 ◽

Vol 46 (2) ◽

pp. 126-131

Author(s):

Tashima Lambert ◽

Tracy Truong ◽

Beverly Gray

Keyword(s):

Randomised Controlled Trial ◽

Primary Outcome ◽

Pain Perception ◽

Controlled Trial ◽

Intrauterine Device ◽

Provider Satisfaction ◽

Pain Scores ◽

Significant Difference ◽

Method Of Placement ◽

Randomised Controlled

Introduction'Slow’ and ‘cough’ techniques for tenaculum placement are commonly used. This trial sought to determine if one method of placement resulted in less pain for patients.MethodsThis study was a randomised controlled trial of patients presenting for intrauterine device placement. Sixty-six participants were randomised to tenaculum placement via the 'slow' method (closure of tenaculum over a 5-s period) versus the 'cough' method (closure of tenaculum at the time of patient’s cough). The primary outcome was pain at time of tenaculum placement measured on a 100 mm visual analogue scale. The study was powered to detect a 16 mm difference in pain. Secondary outcomes included pain with insertion and provider satisfaction with tenaculum grasp. Pain scores were analysed with Wilcoxon rank-sum test.ResultsSixty-six women were enrolled, 33 randomised to each group. Demographics were similar in each group. The primary outcome of pain with tenaculum placement showed a median pain score of 44 (IQR=21, 63) with slow placement and 32 (IQR=19, 54) with cough placement. There was no significant difference in pain scores between methods of tenaculum placement (p=0.16). There was no significant difference in overall pain scores (p=0.12). Provider satisfaction was not associated with one method of placement (p=1). Pre-procedure anxiety was significantly associated with pain at the time of tenaculum placement (p=0.01).ConclusionsNeither the slow method nor cough method is superior for pain reduction or provider satisfaction. Pain with tenaculum use is significantly associated with anxiety.Clinical trial registrationNCT02969421.

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