Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).
Identifieur interne : 000820 ( Main/Exploration ); précédent : 000819; suivant : 000821Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).
Auteurs : Nefyn H. Williams [Royaume-Uni] ; Alison Jenkins [Royaume-Uni] ; Nia Goulden [Royaume-Uni] ; Zoe Hoare [Royaume-Uni] ; Dyfrig A. Hughes [Royaume-Uni] ; Eifiona Wood [Royaume-Uni] ; Nadine E. Foster [Royaume-Uni] ; David Walsh [Royaume-Uni] ; Dawn Carnes [Royaume-Uni] ; Valerie Sparkes [Royaume-Uni] ; Elaine M. Hay [Royaume-Uni] ; John Isaacs [Royaume-Uni] ; Kika Konstantinou [Royaume-Uni] ; Dylan Morrissey [Royaume-Uni] ; Jaro Karppinen [Finlande] ; Stephane Genevay [Suisse] ; Clare Wilkinson [Royaume-Uni]Source :
- Trials [ 1745-6215 ] ; 2018.
Descripteurs français
- KwdFr :
- Adalimumab (administration et posologie), Adalimumab (effets indésirables), Anti-inflammatoires (administration et posologie), Anti-inflammatoires (effets indésirables), Arrêt précoce d'essais cliniques (économie), Association thérapeutique (MeSH), Contrats (MeSH), Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs), Facteur de nécrose tumorale alpha (immunologie), Facteurs temps (MeSH), Humains (MeSH), Injections sous-cutanées (MeSH), Mesure de la douleur (MeSH), Royaume-Uni (MeSH), Résultat thérapeutique (MeSH), Sciatalgie (diagnostic), Sciatalgie (immunologie), Sciatalgie (physiopathologie), Sciatalgie (traitement médicamenteux), Soutien financier à la recherche comme sujet (MeSH), Sélection de patients (MeSH), Techniques de physiothérapie (effets indésirables), Évaluation de l'invalidité (MeSH).
- MESH :
- administration et posologie : Adalimumab, Anti-inflammatoires.
- antagonistes et inhibiteurs : Facteur de nécrose tumorale alpha.
- diagnostic : Sciatalgie.
- effets indésirables : Adalimumab, Anti-inflammatoires, Techniques de physiothérapie.
- immunologie : Facteur de nécrose tumorale alpha, Sciatalgie.
- physiopathologie : Sciatalgie.
- traitement médicamenteux : Sciatalgie.
- économie : Arrêt précoce d'essais cliniques.
- Association thérapeutique, Contrats, Facteurs temps, Humains, Injections sous-cutanées, Mesure de la douleur, Royaume-Uni, Résultat thérapeutique, Soutien financier à la recherche comme sujet, Sélection de patients, Évaluation de l'invalidité.
- Wicri :
- geographic : Royaume-Uni.
English descriptors
- KwdEn :
- Adalimumab (administration & dosage), Adalimumab (adverse effects), Anti-Inflammatory Agents (administration & dosage), Anti-Inflammatory Agents (adverse effects), Combined Modality Therapy (MeSH), Contracts (MeSH), Disability Evaluation (MeSH), Early Termination of Clinical Trials (economics), Humans (MeSH), Injections, Subcutaneous (MeSH), Pain Measurement (MeSH), Patient Selection (MeSH), Physical Therapy Modalities (adverse effects), Research Support as Topic (MeSH), Sciatica (diagnosis), Sciatica (drug therapy), Sciatica (immunology), Sciatica (physiopathology), Time Factors (MeSH), Treatment Outcome (MeSH), Tumor Necrosis Factor-alpha (antagonists & inhibitors), Tumor Necrosis Factor-alpha (immunology), United Kingdom (MeSH).
- MESH :
- chemical , administration & dosage : Adalimumab, Anti-Inflammatory Agents.
- chemical , adverse effects : Adalimumab, Anti-Inflammatory Agents.
- geographic : United Kingdom.
- adverse effects : Physical Therapy Modalities.
- chemical , antagonists & inhibitors : Tumor Necrosis Factor-alpha.
- diagnosis : Sciatica.
- drug therapy : Sciatica.
- economics : Early Termination of Clinical Trials.
- immunology : Sciatica, Tumor Necrosis Factor-alpha.
- physiopathology : Sciatica.
- Combined Modality Therapy, Contracts, Disability Evaluation, Humans, Injections, Subcutaneous, Pain Measurement, Patient Selection, Research Support as Topic, Time Factors, Treatment Outcome.
Abstract
BACKGROUND
Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.
METHODS
A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.
RESULTS
The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.
CONCLUSIONS
Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.
TRIAL REGISTRATION
Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.
DOI: 10.1186/s13063-018-2801-6
PubMed: 30064491
PubMed Central: PMC6069989
Affiliations:
- Finlande, Royaume-Uni, Suisse
- Angleterre, Grand Londres, Nottinghamshire
- Londres, Nottingham
- Université de Londres, Université de Nottingham
Links toward previous steps (curation, corpus...)
Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).</title><author><name sortKey="Williams, Nefyn H" sort="Williams, Nefyn H" uniqKey="Williams N" first="Nefyn H" last="Williams">Nefyn H. Williams</name><affiliation wicri:level="1"><nlm:affiliation>Department of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. nefyn.williams@liverpool.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL</wicri:regionArea><wicri:noRegion>L69 3GL</wicri:noRegion></affiliation></author><author><name sortKey="Jenkins, Alison" sort="Jenkins, Alison" uniqKey="Jenkins A" first="Alison" last="Jenkins">Alison Jenkins</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Goulden, Nia" sort="Goulden, Nia" uniqKey="Goulden N" first="Nia" last="Goulden">Nia Goulden</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Hoare, Zoe" sort="Hoare, Zoe" uniqKey="Hoare Z" first="Zoe" last="Hoare">Zoe Hoare</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Dyfrig A" sort="Hughes, Dyfrig A" uniqKey="Hughes D" first="Dyfrig A" last="Hughes">Dyfrig A. Hughes</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Wood, Eifiona" sort="Wood, Eifiona" uniqKey="Wood E" first="Eifiona" last="Wood">Eifiona Wood</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Foster, Nadine E" sort="Foster, Nadine E" uniqKey="Foster N" first="Nadine E" last="Foster">Nadine E. Foster</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Walsh, David" sort="Walsh, David" uniqKey="Walsh D" first="David" last="Walsh">David Walsh</name><affiliation wicri:level="4"><nlm:affiliation>Arthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham</wicri:regionArea><orgName type="university">Université de Nottingham</orgName><placeName><settlement type="city">Nottingham</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Nottinghamshire</region></placeName></affiliation></author><author><name sortKey="Carnes, Dawn" sort="Carnes, Dawn" uniqKey="Carnes D" first="Dawn" last="Carnes">Dawn Carnes</name><affiliation wicri:level="3"><nlm:affiliation>Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Sparkes, Valerie" sort="Sparkes, Valerie" uniqKey="Sparkes V" first="Valerie" last="Sparkes">Valerie Sparkes</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Science, Cardiff University, Cardiff, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Science, Cardiff University, Cardiff</wicri:regionArea><wicri:noRegion>Cardiff</wicri:noRegion></affiliation></author><author><name sortKey="Hay, Elaine M" sort="Hay, Elaine M" uniqKey="Hay E" first="Elaine M" last="Hay">Elaine M. Hay</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Isaacs, John" sort="Isaacs, John" uniqKey="Isaacs J" first="John" last="Isaacs">John Isaacs</name><affiliation wicri:level="1"><nlm:affiliation>National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne</wicri:regionArea><wicri:noRegion>Newcastle upon Tyne</wicri:noRegion></affiliation></author><author><name sortKey="Konstantinou, Kika" sort="Konstantinou, Kika" uniqKey="Konstantinou K" first="Kika" last="Konstantinou">Kika Konstantinou</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Morrissey, Dylan" sort="Morrissey, Dylan" uniqKey="Morrissey D" first="Dylan" last="Morrissey">Dylan Morrissey</name><affiliation wicri:level="4"><nlm:affiliation>Centre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName type="university">Université de Londres</orgName></affiliation></author><author><name sortKey="Karppinen, Jaro" sort="Karppinen, Jaro" uniqKey="Karppinen J" first="Jaro" last="Karppinen">Jaro Karppinen</name><affiliation wicri:level="1"><nlm:affiliation>Medical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Medical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu</wicri:regionArea><wicri:noRegion>Oulu</wicri:noRegion></affiliation></author><author><name sortKey="Genevay, Stephane" sort="Genevay, Stephane" uniqKey="Genevay S" first="Stephane" last="Genevay">Stephane Genevay</name><affiliation wicri:level="1"><nlm:affiliation>University Hospitals of Geneva, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>University Hospitals of Geneva, Geneva</wicri:regionArea><wicri:noRegion>Geneva</wicri:noRegion></affiliation></author><author><name sortKey="Wilkinson, Clare" sort="Wilkinson, Clare" uniqKey="Wilkinson C" first="Clare" last="Wilkinson">Clare Wilkinson</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2018">2018</date><idno type="RBID">pubmed:30064491</idno><idno type="pmid">30064491</idno><idno type="doi">10.1186/s13063-018-2801-6</idno><idno type="pmc">PMC6069989</idno><idno type="wicri:Area/Main/Corpus">000740</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Corpus" wicri:corpus="PubMed">000740</idno><idno type="wicri:Area/Main/Curation">000740</idno><idno type="wicri:explorRef" wicri:stream="Main" wicri:step="Curation">000740</idno><idno type="wicri:Area/Main/Exploration">000740</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).</title><author><name sortKey="Williams, Nefyn H" sort="Williams, Nefyn H" uniqKey="Williams N" first="Nefyn H" last="Williams">Nefyn H. Williams</name><affiliation wicri:level="1"><nlm:affiliation>Department of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. nefyn.williams@liverpool.ac.uk.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Department of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL</wicri:regionArea><wicri:noRegion>L69 3GL</wicri:noRegion></affiliation></author><author><name sortKey="Jenkins, Alison" sort="Jenkins, Alison" uniqKey="Jenkins A" first="Alison" last="Jenkins">Alison Jenkins</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Goulden, Nia" sort="Goulden, Nia" uniqKey="Goulden N" first="Nia" last="Goulden">Nia Goulden</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Hoare, Zoe" sort="Hoare, Zoe" uniqKey="Hoare Z" first="Zoe" last="Hoare">Zoe Hoare</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Hughes, Dyfrig A" sort="Hughes, Dyfrig A" uniqKey="Hughes D" first="Dyfrig A" last="Hughes">Dyfrig A. Hughes</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Wood, Eifiona" sort="Wood, Eifiona" uniqKey="Wood E" first="Eifiona" last="Wood">Eifiona Wood</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author><author><name sortKey="Foster, Nadine E" sort="Foster, Nadine E" uniqKey="Foster N" first="Nadine E" last="Foster">Nadine E. Foster</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Walsh, David" sort="Walsh, David" uniqKey="Walsh D" first="David" last="Walsh">David Walsh</name><affiliation wicri:level="4"><nlm:affiliation>Arthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham</wicri:regionArea><orgName type="university">Université de Nottingham</orgName><placeName><settlement type="city">Nottingham</settlement><region type="nation">Angleterre</region><region type="région" nuts="1">Nottinghamshire</region></placeName></affiliation></author><author><name sortKey="Carnes, Dawn" sort="Carnes, Dawn" uniqKey="Carnes D" first="Dawn" last="Carnes">Dawn Carnes</name><affiliation wicri:level="3"><nlm:affiliation>Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Sparkes, Valerie" sort="Sparkes, Valerie" uniqKey="Sparkes V" first="Valerie" last="Sparkes">Valerie Sparkes</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Science, Cardiff University, Cardiff, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Science, Cardiff University, Cardiff</wicri:regionArea><wicri:noRegion>Cardiff</wicri:noRegion></affiliation></author><author><name sortKey="Hay, Elaine M" sort="Hay, Elaine M" uniqKey="Hay E" first="Elaine M" last="Hay">Elaine M. Hay</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Isaacs, John" sort="Isaacs, John" uniqKey="Isaacs J" first="John" last="Isaacs">John Isaacs</name><affiliation wicri:level="1"><nlm:affiliation>National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne</wicri:regionArea><wicri:noRegion>Newcastle upon Tyne</wicri:noRegion></affiliation></author><author><name sortKey="Konstantinou, Kika" sort="Konstantinou, Kika" uniqKey="Konstantinou K" first="Kika" last="Konstantinou">Kika Konstantinou</name><affiliation wicri:level="1"><nlm:affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele</wicri:regionArea><wicri:noRegion>Keele</wicri:noRegion></affiliation></author><author><name sortKey="Morrissey, Dylan" sort="Morrissey, Dylan" uniqKey="Morrissey D" first="Dylan" last="Morrissey">Dylan Morrissey</name><affiliation wicri:level="4"><nlm:affiliation>Centre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Centre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London</wicri:regionArea><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName><orgName type="university">Université de Londres</orgName></affiliation></author><author><name sortKey="Karppinen, Jaro" sort="Karppinen, Jaro" uniqKey="Karppinen J" first="Jaro" last="Karppinen">Jaro Karppinen</name><affiliation wicri:level="1"><nlm:affiliation>Medical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland.</nlm:affiliation><country xml:lang="fr">Finlande</country><wicri:regionArea>Medical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu</wicri:regionArea><wicri:noRegion>Oulu</wicri:noRegion></affiliation></author><author><name sortKey="Genevay, Stephane" sort="Genevay, Stephane" uniqKey="Genevay S" first="Stephane" last="Genevay">Stephane Genevay</name><affiliation wicri:level="1"><nlm:affiliation>University Hospitals of Geneva, Geneva, Switzerland.</nlm:affiliation><country xml:lang="fr">Suisse</country><wicri:regionArea>University Hospitals of Geneva, Geneva</wicri:regionArea><wicri:noRegion>Geneva</wicri:noRegion></affiliation></author><author><name sortKey="Wilkinson, Clare" sort="Wilkinson, Clare" uniqKey="Wilkinson C" first="Clare" last="Wilkinson">Clare Wilkinson</name><affiliation wicri:level="1"><nlm:affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</nlm:affiliation><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>School of Healthcare Sciences, Bangor University, Bangor</wicri:regionArea><wicri:noRegion>Bangor</wicri:noRegion></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2018" type="published">2018</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adalimumab (administration & dosage)</term><term>Adalimumab (adverse effects)</term><term>Anti-Inflammatory Agents (administration & dosage)</term><term>Anti-Inflammatory Agents (adverse effects)</term><term>Combined Modality Therapy (MeSH)</term><term>Contracts (MeSH)</term><term>Disability Evaluation (MeSH)</term><term>Early Termination of Clinical Trials (economics)</term><term>Humans (MeSH)</term><term>Injections, Subcutaneous (MeSH)</term><term>Pain Measurement (MeSH)</term><term>Patient Selection (MeSH)</term><term>Physical Therapy Modalities (adverse effects)</term><term>Research Support as Topic (MeSH)</term><term>Sciatica (diagnosis)</term><term>Sciatica (drug therapy)</term><term>Sciatica (immunology)</term><term>Sciatica (physiopathology)</term><term>Time Factors (MeSH)</term><term>Treatment Outcome (MeSH)</term><term>Tumor Necrosis Factor-alpha (antagonists & inhibitors)</term><term>Tumor Necrosis Factor-alpha (immunology)</term><term>United Kingdom (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Adalimumab (administration et posologie)</term><term>Adalimumab (effets indésirables)</term><term>Anti-inflammatoires (administration et posologie)</term><term>Anti-inflammatoires (effets indésirables)</term><term>Arrêt précoce d'essais cliniques (économie)</term><term>Association thérapeutique (MeSH)</term><term>Contrats (MeSH)</term><term>Facteur de nécrose tumorale alpha (antagonistes et inhibiteurs)</term><term>Facteur de nécrose tumorale alpha (immunologie)</term><term>Facteurs temps (MeSH)</term><term>Humains (MeSH)</term><term>Injections sous-cutanées (MeSH)</term><term>Mesure de la douleur (MeSH)</term><term>Royaume-Uni (MeSH)</term><term>Résultat thérapeutique (MeSH)</term><term>Sciatalgie (diagnostic)</term><term>Sciatalgie (immunologie)</term><term>Sciatalgie (physiopathologie)</term><term>Sciatalgie (traitement médicamenteux)</term><term>Soutien financier à la recherche comme sujet (MeSH)</term><term>Sélection de patients (MeSH)</term><term>Techniques de physiothérapie (effets indésirables)</term><term>Évaluation de l'invalidité (MeSH)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Adalimumab</term><term>Anti-Inflammatory Agents</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Adalimumab</term><term>Anti-Inflammatory Agents</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>United Kingdom</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Adalimumab</term><term>Anti-inflammatoires</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Physical Therapy Modalities</term></keywords><keywords scheme="MESH" qualifier="antagonistes et inhibiteurs" xml:lang="fr"><term>Facteur de nécrose tumorale alpha</term></keywords><keywords scheme="MESH" type="chemical" qualifier="antagonists & inhibitors" xml:lang="en"><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Sciatica</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Sciatalgie</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Sciatica</term></keywords><keywords scheme="MESH" qualifier="economics" xml:lang="en"><term>Early Termination of Clinical Trials</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Adalimumab</term><term>Anti-inflammatoires</term><term>Techniques de physiothérapie</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Facteur de nécrose tumorale alpha</term><term>Sciatalgie</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Sciatica</term><term>Tumor Necrosis Factor-alpha</term></keywords><keywords scheme="MESH" qualifier="physiopathologie" xml:lang="fr"><term>Sciatalgie</term></keywords><keywords scheme="MESH" qualifier="physiopathology" xml:lang="en"><term>Sciatica</term></keywords><keywords scheme="MESH" qualifier="traitement médicamenteux" xml:lang="fr"><term>Sciatalgie</term></keywords><keywords scheme="MESH" qualifier="économie" xml:lang="fr"><term>Arrêt précoce d'essais cliniques</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Combined Modality Therapy</term><term>Contracts</term><term>Disability Evaluation</term><term>Humans</term><term>Injections, Subcutaneous</term><term>Pain Measurement</term><term>Patient Selection</term><term>Research Support as Topic</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Association thérapeutique</term><term>Contrats</term><term>Facteurs temps</term><term>Humains</term><term>Injections sous-cutanées</term><term>Mesure de la douleur</term><term>Royaume-Uni</term><term>Résultat thérapeutique</term><term>Soutien financier à la recherche comme sujet</term><term>Sélection de patients</term><term>Évaluation de l'invalidité</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Royaume-Uni</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS</b></p><p>A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.</p></div><div type="abstract" xml:lang="en"><p><b>RESULTS</b></p><p>The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.</p></div><div type="abstract" xml:lang="en"><p><b>CONCLUSIONS</b></p><p>Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">30064491</PMID><DateCompleted><Year>2019</Year><Month>03</Month><Day>14</Day></DateCompleted><DateRevised><Year>2020</Year><Month>03</Month><Day>09</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>19</Volume><Issue>1</Issue><PubDate><Year>2018</Year><Month>Jul</Month><Day>31</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).</ArticleTitle><Pagination><MedlinePgn>408</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/s13063-018-2801-6</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Adalimumab, a biological treatment targeting tumour necrosis factor α, might be useful in sciatica. This paper describes the challenges faced when developing a new treatment pathway for a randomised controlled trial of adalimumab for people with sciatica, as well as the reasons why the trial discussed was stopped early.</AbstractText><AbstractText Label="METHODS" NlmCategory="METHODS">A pragmatic, parallel group, randomised controlled trial with blinded (masked) participants, clinicians, outcome assessment and statistical analysis was conducted in six UK sites. Participants were identified and recruited from general practices, musculoskeletal services and outpatient physiotherapy clinics. They were adults with persistent symptoms of sciatica of 1 to 6 months' duration with moderate to high level of disability. Eligibility was assessed by research physiotherapists according to clinical criteria, and participants were randomised to receive two doses of adalimumab (80 mg then 40 mg 2 weeks later) or saline placebo subcutaneous injections in the posterior lateral thigh. Both groups were referred for a course of physiotherapy. Outcomes were measured at baseline, 6-week, 6-month and 12-month follow-up. The main outcome measure was disability measured using the Oswestry Disability Index. The planned sample size was 332, with the first 50 in an internal pilot phase.</AbstractText><AbstractText Label="RESULTS" NlmCategory="RESULTS">The internal pilot phase was discontinued after 10 months from opening owing to low recruitment (two of the six sites active, eight participants recruited). There were several challenges: contractual delays; one site did not complete contract negotiations, and two sites signed contracts shortly before trial closure; site withdrawal owing to patient safety concerns; difficulties obtaining excess treatment costs; and in the two sites that did recruit, recruitment was slower than planned because of operational issues and low uptake by potential participants.</AbstractText><AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Improved patient care requires robust clinical research within contexts in which treatments can realistically be provided. Step changes in treatment, such as the introduction of biologic treatments for severe sciatica, raise complex issues that can delay trial initiation and retard recruitment. Additional preparatory work might be required before testing novel treatments. A randomised controlled trial of tumour necrosis factor-α blockade is still needed to determine its cost-effectiveness in severe sciatica.</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">Current Controlled Trials, ISRCTN14569274 . Registered on 15 December 2014.</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Williams</LastName><ForeName>Nefyn H</ForeName><Initials>NH</Initials><Identifier Source="ORCID">http://orcid.org/0000-0002-8078-409X</Identifier><AffiliationInfo><Affiliation>Department of Health Services Research, University of Liverpool, Waterhouse Block B, 1-5 Brownlow Street, Liverpool, L69 3GL, UK. nefyn.williams@liverpool.ac.uk.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Jenkins</LastName><ForeName>Alison</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Goulden</LastName><ForeName>Nia</ForeName><Initials>N</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hoare</LastName><ForeName>Zoe</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hughes</LastName><ForeName>Dyfrig A</ForeName><Initials>DA</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wood</LastName><ForeName>Eifiona</ForeName><Initials>E</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Foster</LastName><ForeName>Nadine E</ForeName><Initials>NE</Initials><AffiliationInfo><Affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Walsh</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Arthritis Research UK Pain Centre and National Institute for Health Research Nottingham Biomedical Research Centre, School of Medicine, University of Nottingham, Nottingham, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Carnes</LastName><ForeName>Dawn</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Centre for Primary Care and Public Health, Barts and the London School of Medicine and Dentistry, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Sparkes</LastName><ForeName>Valerie</ForeName><Initials>V</Initials><AffiliationInfo><Affiliation>School of Healthcare Science, Cardiff University, Cardiff, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Hay</LastName><ForeName>Elaine M</ForeName><Initials>EM</Initials><AffiliationInfo><Affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Isaacs</LastName><ForeName>John</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>National Institute for Health Research Newcastle Biomedical Research Centre, Newcastle upon Tyne Hospitals NHS Foundation Trust and Newcastle University, Newcastle upon Tyne, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Konstantinou</LastName><ForeName>Kika</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Arthritis Research UK Primary Care Centre, Research Institute for Primary Care and Health Sciences, Keele University, Keele, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Morrissey</LastName><ForeName>Dylan</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Centre for Sports and Exercise Medicine, William Harvey Research Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Karppinen</LastName><ForeName>Jaro</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Medical Research Centre Oulu, University of Oulu and Oulu University Hospital, Oulu, Finland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Genevay</LastName><ForeName>Stephane</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>University Hospitals of Geneva, Geneva, Switzerland.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilkinson</LastName><ForeName>Clare</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>School of Healthcare Sciences, Bangor University, Bangor, UK.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><GrantList CompleteYN="Y"><Grant><GrantID>CAT SCL-2013-04-003</GrantID><Acronym>DH_</Acronym><Agency>Department of Health</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>HTA/12/201/02</GrantID><Acronym>DH_</Acronym><Agency>Department of Health</Agency><Country>United Kingdom</Country></Grant><Grant><GrantID>12/201/02</GrantID><Agency>Health Technology Assessment Programme</Agency><Country></Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D065007">Pragmatic Clinical Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2018</Year><Month>07</Month><Day>31</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Trials</MedlineTA><NlmUniqueID>101263253</NlmUniqueID><ISSNLinking>1745-6215</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D000893">Anti-Inflammatory Agents</NameOfSubstance></Chemical><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D014409">Tumor Necrosis Factor-alpha</NameOfSubstance></Chemical><Chemical><RegistryNumber>FYS6T7F842</RegistryNumber><NameOfSubstance UI="D000068879">Adalimumab</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><MeshHeadingList><MeshHeading><DescriptorName UI="D000068879" MajorTopicYN="N">Adalimumab</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000893" MajorTopicYN="N">Anti-Inflammatory Agents</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="Y">administration & dosage</QualifierName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D003131" MajorTopicYN="N">Combined Modality Therapy</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D032982" MajorTopicYN="N">Contracts</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004185" MajorTopicYN="N">Disability Evaluation</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D057239" MajorTopicYN="Y">Early Termination of Clinical Trials</DescriptorName><QualifierName UI="Q000191" MajorTopicYN="N">economics</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D007279" MajorTopicYN="N">Injections, Subcutaneous</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D010147" MajorTopicYN="N">Pain Measurement</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018579" MajorTopicYN="N">Patient Selection</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D026741" MajorTopicYN="Y">Physical Therapy Modalities</DescriptorName><QualifierName UI="Q000009" MajorTopicYN="N">adverse effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D012109" MajorTopicYN="N">Research Support as Topic</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D012585" MajorTopicYN="N">Sciatica</DescriptorName><QualifierName UI="Q000175" MajorTopicYN="N">diagnosis</QualifierName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName><QualifierName UI="Q000503" MajorTopicYN="N">physiopathology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D013997" MajorTopicYN="N">Time Factors</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D014409" MajorTopicYN="N">Tumor Necrosis Factor-alpha</DescriptorName><QualifierName UI="Q000037" MajorTopicYN="N">antagonists & inhibitors</QualifierName><QualifierName UI="Q000276" MajorTopicYN="N">immunology</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D006113" MajorTopicYN="N" Type="Geographic">United Kingdom</DescriptorName></MeshHeading></MeshHeadingList><KeywordList Owner="NOTNLM"><Keyword MajorTopicYN="N">Adalimumab</Keyword><Keyword MajorTopicYN="N">Anti-TNF-α</Keyword><Keyword MajorTopicYN="N">Biological agents</Keyword><Keyword MajorTopicYN="N">Economic evaluation</Keyword><Keyword MajorTopicYN="N">Feasibility</Keyword><Keyword MajorTopicYN="N">Randomised controlled trial</Keyword><Keyword MajorTopicYN="N">Sciatica</Keyword></KeywordList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="received"><Year>2017</Year><Month>12</Month><Day>04</Day></PubMedPubDate><PubMedPubDate PubStatus="accepted"><Year>2018</Year><Month>07</Month><Day>09</Day></PubMedPubDate><PubMedPubDate PubStatus="entrez"><Year>2018</Year><Month>8</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2018</Year><Month>8</Month><Day>2</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2019</Year><Month>3</Month><Day>15</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>epublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">30064491</ArticleId><ArticleId IdType="doi">10.1186/s13063-018-2801-6</ArticleId><ArticleId IdType="pii">10.1186/s13063-018-2801-6</ArticleId><ArticleId IdType="pmc">PMC6069989</ArticleId></ArticleIdList><ReferenceList><Reference><Citation>BMJ. 2007 Jun 23;334(7607):1313-7</Citation><ArticleIdList><ArticleId IdType="pubmed">17585160</ArticleId></ArticleIdList></Reference><Reference><Citation>J Clin Epidemiol. 2004 Feb;57(2):174-9</Citation><ArticleIdList><ArticleId IdType="pubmed">15125627</ArticleId></ArticleIdList></Reference><Reference><Citation>Pain. 1995 Sep;62(3):363-72</Citation><ArticleIdList><ArticleId IdType="pubmed">8657437</ArticleId></ArticleIdList></Reference><Reference><Citation>Pain. 1995 Aug;62(2):233-40</Citation><ArticleIdList><ArticleId IdType="pubmed">8545149</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Musculoskelet Disord. 2015 Nov 04;16:332</Citation><ArticleIdList><ArticleId IdType="pubmed">26537894</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 1983 Mar;8(2):141-4</Citation><ArticleIdList><ArticleId IdType="pubmed">6222486</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 1993 Sep 1;18(11):1433-8</Citation><ArticleIdList><ArticleId IdType="pubmed">8235813</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ Open. 2012 Jan 06;2(1):e000496</Citation><ArticleIdList><ArticleId IdType="pubmed">22228729</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur Spine J. 2010 Feb;19(2):263-9</Citation><ArticleIdList><ArticleId IdType="pubmed">19488793</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur Spine J. 2007 Jul;16(7):881-99</Citation><ArticleIdList><ArticleId IdType="pubmed">17415595</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 1984 Jan-Feb;9(1):7-15</Citation><ArticleIdList><ArticleId IdType="pubmed">6372124</ArticleId></ArticleIdList></Reference><Reference><Citation>Trials. 2016 Jun 08;17(1):283</Citation><ArticleIdList><ArticleId IdType="pubmed">27278130</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 2008 Oct 15;33(22):2464-72</Citation><ArticleIdList><ArticleId IdType="pubmed">18923325</ArticleId></ArticleIdList></Reference><Reference><Citation>JAMA. 1992 Aug 12;268(6):760-5</Citation><ArticleIdList><ArticleId IdType="pubmed">1386391</ArticleId></ArticleIdList></Reference><Reference><Citation>J Spinal Disord Tech. 2010 Feb;23(1):74-7</Citation><ArticleIdList><ArticleId IdType="pubmed">20072036</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 1992 Oct;17(10):1205-12</Citation><ArticleIdList><ArticleId IdType="pubmed">1440010</ArticleId></ArticleIdList></Reference><Reference><Citation>Semin Arthritis Rheum. 1998 Aug;28(1):60-71</Citation><ArticleIdList><ArticleId IdType="pubmed">9726337</ArticleId></ArticleIdList></Reference><Reference><Citation>BMJ Open. 2013 Feb 07;3(2):null</Citation><ArticleIdList><ArticleId IdType="pubmed">23396504</ArticleId></ArticleIdList></Reference><Reference><Citation>Acta Psychiatr Scand. 1983 Jun;67(6):361-70</Citation><ArticleIdList><ArticleId IdType="pubmed">6880820</ArticleId></ArticleIdList></Reference><Reference><Citation>Ann Pharmacother. 2017 Dec;51(12):1041-1052</Citation><ArticleIdList><ArticleId IdType="pubmed">28745066</ArticleId></ArticleIdList></Reference><Reference><Citation>Appl Health Econ Health Policy. 2013 Jun;11(3):155-61</Citation><ArticleIdList><ArticleId IdType="pubmed">23529715</ArticleId></ArticleIdList></Reference><Reference><Citation>Health Policy. 1990 Dec;16(3):199-208</Citation><ArticleIdList><ArticleId IdType="pubmed">10109801</ArticleId></ArticleIdList></Reference><Reference><Citation>Trials. 2013 Jun 09;14:166</Citation><ArticleIdList><ArticleId IdType="pubmed">23758961</ArticleId></ArticleIdList></Reference><Reference><Citation>Rheumatology (Oxford). 2004 Feb;43(2):119-21</Citation><ArticleIdList><ArticleId IdType="pubmed">13130150</ArticleId></ArticleIdList></Reference><Reference><Citation>Stat Med. 2011 Apr 30;30(9):922-34</Citation><ArticleIdList><ArticleId IdType="pubmed">21284014</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Musculoskelet Disord. 2017 Apr 26;18(1):172</Citation><ArticleIdList><ArticleId IdType="pubmed">28441971</ArticleId></ArticleIdList></Reference><Reference><Citation>Value Health. 2010 Dec;13(8):867-72</Citation><ArticleIdList><ArticleId IdType="pubmed">20946187</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur J Pain. 2007 Feb;11(2):153-63</Citation><ArticleIdList><ArticleId IdType="pubmed">16446108</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 2012 Apr 1;37(7):531-42</Citation><ArticleIdList><ArticleId IdType="pubmed">21494193</ArticleId></ArticleIdList></Reference><Reference><Citation>Pain. 2006 Mar;121(1-2):126-32</Citation><ArticleIdList><ArticleId IdType="pubmed">16472916</ArticleId></ArticleIdList></Reference><Reference><Citation>Acta Neurochir (Wien). 2010 Sep;152(9):1549-53; discussion 1553</Citation><ArticleIdList><ArticleId IdType="pubmed">20467761</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine J. 2015 Jun 1;15(6):1461-77</Citation><ArticleIdList><ArticleId IdType="pubmed">24412033</ArticleId></ArticleIdList></Reference><Reference><Citation>Eur Spine J. 2013 Sep;22(9):1921-35</Citation><ArticleIdList><ArticleId IdType="pubmed">23529742</ArticleId></ArticleIdList></Reference><Reference><Citation>Spine (Phila Pa 1976). 2005 Aug 15;30(16):E455-8</Citation><ArticleIdList><ArticleId IdType="pubmed">16103839</ArticleId></ArticleIdList></Reference><Reference><Citation>BMC Med Res Methodol. 2006 Jul 19;6:34</Citation><ArticleIdList><ArticleId IdType="pubmed">16854229</ArticleId></ArticleIdList></Reference><Reference><Citation>Physiotherapy. 1980 Aug;66(8):271-3</Citation><ArticleIdList><ArticleId IdType="pubmed">6450426</ArticleId></ArticleIdList></Reference><Reference><Citation>Arthritis Rheum. 2008 May 15;59(5):632-41</Citation><ArticleIdList><ArticleId IdType="pubmed">18438893</ArticleId></ArticleIdList></Reference></ReferenceList></PubmedData></pubmed><affiliations><list><country><li>Finlande</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Nottinghamshire</li></region><settlement><li>Londres</li><li>Nottingham</li></settlement><orgName><li>Université de Londres</li><li>Université de Nottingham</li></orgName></list><tree><country name="Royaume-Uni"><noRegion><name sortKey="Williams, Nefyn H" sort="Williams, Nefyn H" uniqKey="Williams N" first="Nefyn H" last="Williams">Nefyn H. Williams</name></noRegion><name sortKey="Carnes, Dawn" sort="Carnes, Dawn" uniqKey="Carnes D" first="Dawn" last="Carnes">Dawn Carnes</name><name sortKey="Foster, Nadine E" sort="Foster, Nadine E" uniqKey="Foster N" first="Nadine E" last="Foster">Nadine E. Foster</name><name sortKey="Goulden, Nia" sort="Goulden, Nia" uniqKey="Goulden N" first="Nia" last="Goulden">Nia Goulden</name><name sortKey="Hay, Elaine M" sort="Hay, Elaine M" uniqKey="Hay E" first="Elaine M" last="Hay">Elaine M. Hay</name><name sortKey="Hoare, Zoe" sort="Hoare, Zoe" uniqKey="Hoare Z" first="Zoe" last="Hoare">Zoe Hoare</name><name sortKey="Hughes, Dyfrig A" sort="Hughes, Dyfrig A" uniqKey="Hughes D" first="Dyfrig A" last="Hughes">Dyfrig A. Hughes</name><name sortKey="Isaacs, John" sort="Isaacs, John" uniqKey="Isaacs J" first="John" last="Isaacs">John Isaacs</name><name sortKey="Jenkins, Alison" sort="Jenkins, Alison" uniqKey="Jenkins A" first="Alison" last="Jenkins">Alison Jenkins</name><name sortKey="Konstantinou, Kika" sort="Konstantinou, Kika" uniqKey="Konstantinou K" first="Kika" last="Konstantinou">Kika Konstantinou</name><name sortKey="Morrissey, Dylan" sort="Morrissey, Dylan" uniqKey="Morrissey D" first="Dylan" last="Morrissey">Dylan Morrissey</name><name sortKey="Sparkes, Valerie" sort="Sparkes, Valerie" uniqKey="Sparkes V" first="Valerie" last="Sparkes">Valerie Sparkes</name><name sortKey="Walsh, David" sort="Walsh, David" uniqKey="Walsh D" first="David" last="Walsh">David Walsh</name><name sortKey="Wilkinson, Clare" sort="Wilkinson, Clare" uniqKey="Wilkinson C" first="Clare" last="Wilkinson">Clare Wilkinson</name><name sortKey="Wood, Eifiona" sort="Wood, Eifiona" uniqKey="Wood E" first="Eifiona" last="Wood">Eifiona Wood</name></country><country name="Finlande"><noRegion><name sortKey="Karppinen, Jaro" sort="Karppinen, Jaro" uniqKey="Karppinen J" first="Jaro" last="Karppinen">Jaro Karppinen</name></noRegion></country><country name="Suisse"><noRegion><name sortKey="Genevay, Stephane" sort="Genevay, Stephane" uniqKey="Genevay S" first="Stephane" last="Genevay">Stephane Genevay</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Bois/explor/BiopestPeptidV1/Data/Main/Exploration
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000820 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd -nk 000820 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Bois
|area= BiopestPeptidV1
|flux= Main
|étape= Exploration
|type= RBID
|clé= pubmed:30064491
|texte= Lessons learnt from a discontinued randomised controlled trial: adalimumab injection compared with placebo for patients receiving physiotherapy treatment for sciatica (Subcutaneous Injection of Adalimumab Trial compared with Control: SCIATiC).
}}
Pour générer des pages wiki
HfdIndexSelect -h $EXPLOR_AREA/Data/Main/Exploration/RBID.i -Sk "pubmed:30064491" \
| HfdSelect -Kh $EXPLOR_AREA/Data/Main/Exploration/biblio.hfd \
| NlmPubMed2Wicri -a BiopestPeptidV1
| This area was generated with Dilib version V0.6.38. |  |