SPIRIT provides evidence-based guidance to facilitate the writing of protocols and improve the completeness of their content. High quality protocols can enable rigorous trial implementation, enhance the quality and efficiency of protocol review, and reduce the burden of avoidable protocol amendments. These benefits can translate into better, more transparent trials that incur less time and costs to conduct and review.
The impact of SPIRIT on the quality of clinical trial protocols depends on widespread endorsement and implementation by trial investigators, sponsors, funders, research ethics committees/institutional review boards, trial registries, journals, regulators, and educators. Empirical evidence supports the association between the endorsement of reporting guidelines and the quality of reporting in journal publications (Turner L et al, Syst Rev 2012;1:60).
Endorsement of the SPIRIT Statement can be given at 3 levels:
- General statement of support;
- Specific statement encouraging investigators to adhere to SPIRIT when they develop their protocols;
- Explicit statement requiring that trial protocols adhere to SPIRIT. Active implementation of a strong endorsement policy has been shown to be most effective at promoting adherence to reporting guidelines such as CONSORT (Hopewell S et al, BMJ 2012;344:e4178).
The following groups have endorsed the SPIRIT 2013 Statement:
- AAS Open Research
- Acta Anaesthesiologica Scandinavica
- American Cancer Society Journals
- American Heart Association (AHA) Journals
- American Journal of Audiology
- American Journal of Speech-Language Pathology
- Annals of Internal Medicine
- Applied Adhesion Science
- Asian Pacific Journal of Cancer Prevention
- Australian Critical Care
- Balkan Medical Journal
- BMC Addiction Science & Clinical Practice
- BMC Anesthesiology
- BMC Archives of Public Health
- BMC Borderline Personality Disorder and Emotion Dysregulation
- BMC Cancer
- BMC Cardiovascular Diabetology
- BMC Cardiovascular Disorders
- BMC Chiropractic & Manual Therapies
- BMC Clinical and Translational Allergy
- BMC Complimentary and Alternative Medicine
- BMC Dermatology
- BMC Diagnostic Pathology
- BMC Ear, Nose and Throat Disorders
- BMC Emergency Medicine
- BMC Endocrine Disorders
- BMC Extreme Physiology & Medicine
- BMC Primary Care
- BMC Fluids and Barriers of the CNS
- BMC Gastroenterology
- BMC Geriatrics
- BMC Health and Justice
- BMC Health and Quality of Life Outcomes
- BMC Health Services Research
- BMC Hematology
- BMC Implementation Science
- BMC Infectious Diseases
- BMC International Breastfeeding Journal
- BMC International Health and Human Rights
- BMC International Journal for Equity and Health
- BMC International Journal of Mental Health Systems
- BMC Journal of Animal Science and Biotechnology
- BMC Journal of Cardiothoracic Surgery
- BMC Journal of Cardiovascular Magnetic Resonance
- BMC Journal of Eating Disorders
- BMC Journal of Occupational Medicine and Toxicology
- BMC Journal of Orthopaedic Surgery and Research
- BMC Journal of Translational Medicine
- BMC Medical Education
- BMC Medical Ethics
- BMC Medical Genetics
- BMC Medical Imaging
- BMC Medical Informatics and Decision Making
- BMC Medical Research Methodology
- BMC Musculoskeletal Disorders
- BMC Nephrology
- BMC Neurology
- BMC Nursing
- BMC Nutrition
- BMC Obesity
- BMC Ophthalmology
- BMC Oral Health
- BMC Palliative Care
- BMC Pediatrics
- BMC Pharmacology and Toxicology
- BMC Pilot and Feasibility Studies
- BMC Pregnancy and Childbirth
- BMC Psychiatry
- BMC Psychology
- BMC Public Health
- BMC Pulmonary Medicine
- BMC Radiation Oncology
- BMC Reproductive Health
- BMC Scandinavian Journal of Trauma, Resuscitation and Emergency Medicine
- BMC Skeletal Muscle
- BMC Sport Science, Medicine and Rehabilitation
- BMC Surgery
- BMC Systematic Reviews
- BMC Trials
- BMC Urology
- BMC Virology Journal
- BMC Women’s Health
- BMC World Journal of Emergency Surgery
- BMJ
- BMJ Open
- Brazilian Journal of Physical Therapy
- British Journal of Nutrition
- British Journal of Radiology
- Cellular and Molecular Medicine Research
- Clinical Nutrition ESPEN
- CMAJ Open
- ERJ Open Research
- European Journal of Midwifery
- European Respiratory Journal
- F1000 Research
- Family Practice
- Gates Open Research
- HRB Open Research
- Infection, Disease & Health
- Intensive Care Medicine
- International Journal of Clinical Trials
- International Journal of Stroke
- International Journal of Therapeutic Massage and Bodywork
- JAMA
- JAMA Cardiology
- JAMA Dermatology
- JAMA Health Forum
- JAMA Internal Medicine
- JAMA Network Open
- JAMA Neurology
- JAMA Oncology
- JAMA Ophthalmology
- JAMA Otolaryngology-Head and Neck Surgery
- JAMA Pediatrics
- JAMA Psychiatry
- JAMA Surgery
- Journal of Acupuncture and Meridian Studies
- Journal of Advanced Nursing
- Journal of American Physical Therapy Association
- Journal of Breast Cancer
- Journal of Clinical Medicine Research
- Journal of Clinical Periodontology
- Journal of Comorbidity
- Journal of Consulting and Clinical Psychology
- Journal of Emergency and Critical Care Medicine
- Journal of Experimental Orthopaedics
- Journal of Gynecologic Oncology
- Journal of Hematology
- Journal of Music Therapy
- Journal of Oral Research
- Journal of Pakistan Medical Association
- Journal of Pediatrics
- Journal of Speech, Language and Hearing Research
- Journal of the Royal College of Physicians of Edinburgh
- Journal of Thoracic Disease
- Kidney Research and Clinical Practice
- Language, Speech, and Hearing Services in Schools
- Medicine
- Nephrology Dialysis Transplantation
- Open Research Europe
- Physical Therapy and Rehabilitation Journal
- Physiotherapy
- PLOS ONE
- Population Medicine
- SpringerPlus
- Substance Abuse Journal
- The Lancet
- Tobacco Induced Diseases
- Tobacco Prevention & Cessation
- Turkish Journal of Emergency Medicine
- Wellcome Open Research
- Xenotransplantation
- The Children’s Hospital of Philadelphia (CHOP) Institutional Review Board
- Health Research Authority (UK)
- Health Research Ethics Application (Australia)
- National Health and Medical Research Council (NHMRC) Clinical Trials Centre (Australia)
- Australian Clinical Trials
- Association of the British Pharmaceutical Industry
- GlaxoSmithKline
- Janssen Pharmaceutical Companies of Johnson & Johnson
- NHS Health Technology Assessment Programme
- National Centre for Clinical Research on Emerging Drugs (Australia)
- National Institute for Health Research (UK)
- Swiss National Science Foundation
- United States Agency for International Development (USAID)
- Africa Grid Science Gateway
- Alberta Clinical Research Consortium (Canada)
- Australian Clinical Trials Alliance
- Australasian Leukaemia & Lymphoma Group (ALLG)
- Cambridge Clinical Trials Unit (UK)
- Centre for Evidence Based Dentistry (Cairo, Egypt)
- Centre for Evidence in Transplantation and the European Society for Organ Transplantation (CET-ESOT)
- Centre for Intervention Science in Maternal and Child Health (CISMAC), University of Bergen
- CenTrial GmbH (Germany)
- Chris O’Brien Lifehouse (Australia)
- Clinical Trials Ontario (Canada)
- Delos Clinical (Spain)
- European & Developing Countries Clinical Trials Partnership (EDCTP)
- European Clinical Research Infrastructures Network (ECRIN) – Translational Access Activity
- European Society of Minimally Invasive Neurorlogical Therapy (ESMINT)
- International Society of Nephrology (ISN)
- Medical Research Council Clinical Trials Unit (UK)
- NCIC Clinical Trials Group (Canada)
- Network of Networks (N2 Canada)
- Oregon Clinical and Translational Research Institute (US)
- Oxford Clinical Trials Research Unit (UK)
- Royal National Orthopaedic Hospital Research and Innovation Centre (UK)
- Shifa Clinical Research Center (Pakistan)
- St. Vincent’s Hospital Melbourne (Australia)
- Sunnybrook Research Institute (Canada)
- Swiss Ethics Committees on research involving humans
- The Royal Melbourne Hospital (Australia)
- Toronto Academic Health Science Network (TAHSN)
- UC Davis Clinical Trials Resource Group (US)
- University College London Clinical Trials Unit (UK)
- University of Melbourne
- University of Nevada, Las Vegas: The PRACTICE (US)
- University of Queensland
- University of Tasmania
- World Association of Medical Editors