Lee Middleton
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View article: Baseline characteristics of people experiencing homelessness in the PHOENIx community pharmacy multicentre pilot randomised controlled trial
Baseline characteristics of people experiencing homelessness in the PHOENIx community pharmacy multicentre pilot randomised controlled trial Open
Background People experiencing homelessness (PEH) are amongst the most marginalised populations in the society. Despite facing extreme health inequalities and poorer outcomes than the general population, they are under-represented in clini…
View article: Early detection and bundled treatment of postpartum haemorrhage with the E-MOTIVE intervention: a prospective pre–post intervention study in Pakistan
Early detection and bundled treatment of postpartum haemorrhage with the E-MOTIVE intervention: a prospective pre–post intervention study in Pakistan Open
View article: 5-010 Preparatory work for a multi-arm, multi-stage randomised controlled trial of adjunctive diuretics in patients hospitalisation with heart failure: pre-mammoth-HF
5-010 Preparatory work for a multi-arm, multi-stage randomised controlled trial of adjunctive diuretics in patients hospitalisation with heart failure: pre-mammoth-HF Open
View article: Thoracic epidural versus paravertebral blockade for reducing chronic post-thoracotomy pain (TOPIC-2): an open-label, allocation-concealed, multicentre, randomised controlled trial
Thoracic epidural versus paravertebral blockade for reducing chronic post-thoracotomy pain (TOPIC-2): an open-label, allocation-concealed, multicentre, randomised controlled trial Open
Structured Abstract Importance Many patients undergoing thoracotomy suffer from debilitating chronic post-thoracotomy pain (CPTP) lasting months or years postoperatively. The effectiveness of the commonly used two analgesic techniques, par…
View article: The cost-effectiveness of thoracic epidural versus paravertebral blockade in reducing chronic post-thoracotomy pain - a trial-based economic evaluation
The cost-effectiveness of thoracic epidural versus paravertebral blockade in reducing chronic post-thoracotomy pain - a trial-based economic evaluation Open
Thoracotomy surgery is associated with high levels of acute pain and can lead to chronic post-surgical pain. Two methods of regional analgesia are commonly used in patients undergoing thoracotomy surgery, thoracic epidural blockade (TEB) a…
View article: Feasibility, acceptability and appropriateness of laparoscopic versus abdominal hysterectomy for women and healthcare professionals: the LAVA trial qualitative process evaluation
Feasibility, acceptability and appropriateness of laparoscopic versus abdominal hysterectomy for women and healthcare professionals: the LAVA trial qualitative process evaluation Open
Background Laparoscopic hysterectomies performed for benign gynaecological conditions are increasing. However, there is a lack of up-to-date evidence on their surgical outcomes when compared with abdominal hysterectomy. The LAparoscopic Ve…
View article: Comparison of complications and recovery after laparoscopic and abdominal hysterectomy for benign disease: the LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial
Comparison of complications and recovery after laparoscopic and abdominal hysterectomy for benign disease: the LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial Open
Objective To compare recovery after laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH). Design A parallel, open, non-inferiority, multicentre, randomised controlled, expertise-based surgery trial. Setting 10 NHS (National Healt…
View article: Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx) Community Pharmacy-Based Pilot Randomized Controlled Trial
Pharmacy Homeless Outreach Engagement Non-medical Independent Prescribing Rx (PHOENIx) Community Pharmacy-Based Pilot Randomized Controlled Trial Open
Randomized controlled trials (RCTs) aiming to address the multiple health and social challenges of people experiencing homelessness (PEH) are lacking. Here we report the findings from a multicenter, open, pilot RCT. The intervention involv…
View article: Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) community pharmacy based pilot randomised controlled trial
Pharmacy Homeless Outreach Engagement Non-medical Independent prescribing Rx (PHOENIx) community pharmacy based pilot randomised controlled trial Open
Randomised controlled trials (RCTs) aiming to address the multiple health and social challenges of people experiencing homelessness (PEH) are lacking. Here we report the findings from a multicentre, open, pilot RCT. The intervention involv…
View article: Does combination treatment with progesterone and vaginal cervical cerclage improve pregnancy outcomes in women at high risk of preterm birth? A retrospective, secondary analysis of the C-STICH suture thread for cerclage trial data
Does combination treatment with progesterone and vaginal cervical cerclage improve pregnancy outcomes in women at high risk of preterm birth? A retrospective, secondary analysis of the C-STICH suture thread for cerclage trial data Open
Background Vaginal cervical cerclage and progesterone are established treatments for prevention of pregnancy loss and prematurity. There is limited data to assess the effect of these treatments in combination. Objective To investigate the …
View article: Estimating relative risks and risk differences in randomised controlled trials: a systematic review of current practice
Estimating relative risks and risk differences in randomised controlled trials: a systematic review of current practice Open
View article: Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial
Cost-effectiveness of long-acting progestogens versus the combined oral contraceptives pill for preventing recurrence of endometriosis-related pain following surgery: an economic evaluation alongside the PRE-EMPT trial Open
Objectives To evaluate the cost-effectiveness of long-acting progestogens (LAP), including levonorgestrel-releasing intrauterine system (LNG-IUS) and depot-medroxyprogesterone acetate (DMPA), compared with the combined oral contraceptives …
View article: Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT
Preventing recurrence of endometriosis-related pain by means of long-acting progestogen therapy: the PRE-EMPT RCT Open
Background Endometriosis affects 1 in 10 women, many of whom have surgery for persistent pain. Recurrence of symptoms following an operation is common. Although hormonal treatment can reduce this risk, there is uncertainty about the best o…
View article: Cerclage suture type to prevent pregnancy loss in women requiring a vaginal cervical cerclage: the C-STICH RCT
Cerclage suture type to prevent pregnancy loss in women requiring a vaginal cervical cerclage: the C-STICH RCT Open
Background Second trimester miscarriage and preterm birth is a significant global problem. Surgical cervical cerclage is performed to prevent pregnancy loss and preterm birth. It utilises either a monofilament or braided suture. It is hypo…
View article: A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial
A cost-effectiveness analysis of early detection and bundled treatment of postpartum hemorrhage alongside the E-MOTIVE trial Open
View article: Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial
Long acting progestogens versus combined oral contraceptive pill for preventing recurrence of endometriosis related pain: the PRE-EMPT pragmatic, parallel group, open label, randomised controlled trial Open
Objectives To evaluate the clinical effectiveness of long acting progestogens compared with the combined oral contraceptive pill in preventing recurrence of endometriosis related pain. Design The PRE-EMPT (preventing recurrence of endometr…
View article: Lessons learnt from the multi-centre LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial
Lessons learnt from the multi-centre LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial Open
Background: The LAparoscopic Versus Abdominal hysterectomy (LAVA) randomised controlled trial comparing laparoscopic hysterectomy (LH) and abdominal hysterectomy (AH) closed prematurely on the grounds of futility. Here we identify the chal…
View article: Early detection and treatment of postpartum haemorrhage: a cost-effectiveness analysis of the E-MOTIVE trial
Early detection and treatment of postpartum haemorrhage: a cost-effectiveness analysis of the E-MOTIVE trial Open
Background Timely detection and treatment of postpartum haemorrhage (PPH) are crucial to prevent complications or death. A calibrated blood-collection drape can help provide objective, accurate, and early diagnosis of PPH and a treatment b…
View article: Issue Information
Issue Information Open
View article: Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2)
Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy pain: 2 (TOPIC 2) Open
View article: Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study
Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding: the UCON randomised controlled trial and mechanism of action study Open
Background Heavy menstrual bleeding affects one in four women and negatively impacts quality of life. The levonorgestrel-releasing intrauterine system is an effective long-term treatment but is discontinued by many due to unpredictable ble…
View article: LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial
LAparoscopic Versus Abdominal hysterectomy (LAVA): protocol of a randomised controlled trial Open
Introduction There is uncertainty about the advantages and disadvantages of laparoscopic hysterectomy compared with abdominal hysterectomy, particularly the relative rate of complications of the two procedures. While uptake of laparoscopic…
View article: Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy Pain: 2 (TOPIC 2)
Study protocol for a randomised controlled trial to investigate the effectiveness of thoracic epidural and paravertebral blockade in reducing chronic post-thoracotomy Pain: 2 (TOPIC 2) Open
Background Thoracotomy is considered one of the most painful surgical procedures and can cause debilitating chronic post-surgical pain lasting months or years postoperatively. Aggressive management of acute pain resulting from thoracotomy …
View article: O-141 Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial
O-141 Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial Open
Study question Is a combination of parenteral methotrexate and oral gefitinib more effective than methotrexate alone in the treatment of tubal ectopic pregnancy? Summary answer In women with a tubal ectopic pregnancy, adding oral gefitinib…
View article: Gefitinib and methotrexate to resolve tubal ectopic pregnancy: the GEM3 RCT
Gefitinib and methotrexate to resolve tubal ectopic pregnancy: the GEM3 RCT Open
Background Tubal ectopic pregnancies can cause significant morbidity or even death. Current treatment is with methotrexate or surgery. However, methotrexate treatment can fail in approximately 30% of women. Gefitinib, an epidermal growth f…
View article: Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial
Ulipristal acetate versus levonorgestrel-releasing intrauterine system for heavy menstrual bleeding (UCON): a randomised controlled phase III trial Open
View article: Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage
Randomized Trial of Early Detection and Treatment of Postpartum Hemorrhage Open
Early detection of postpartum hemorrhage and use of bundled treatment led to a lower risk of the primary outcome, a composite of severe postpartum hemorrhage, laparotomy for bleeding, or death from bleeding, than usual care among patients …
View article: Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study
Protocol for a pilot randomised controlled trial to evaluate integrated support from pharmacist independent prescriber and third sector worker for people experiencing homelessness: the PHOENIx community pharmacy study Open
View article: Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial
Combination of gefitinib and methotrexate to treat tubal ectopic pregnancy (GEM3): a multicentre, randomised, double-blind, placebo-controlled trial Open
National Institute of Health Research.
View article: A Randomized Trial of Autologous Chondrocyte Implantation Versus Alternative Forms of Surgical Cartilage Management in Patients With a Failed Primary Treatment for Chondral or Osteochondral Defects in the Knee
A Randomized Trial of Autologous Chondrocyte Implantation Versus Alternative Forms of Surgical Cartilage Management in Patients With a Failed Primary Treatment for Chondral or Osteochondral Defects in the Knee Open
Background: There are limited randomized controlled trials with long-term outcomes comparing autologous chondrocyte implantation (ACI) versus alternative forms of surgical cartilage management within the knee. Purpose: To determine at 5 ye…