RHS register
Randomised health services studies (RHS) refers to research on health service effectiveness which use randomised design in interventions carried out in routine health care.
Randomized healthservices study of Human Papillomavirus-based management of low-grade cytological abnormalities
Trial number: 001_2010_6_RHS
Lead researcher: Lena Dillner
Primary institution: Oncology Center, Karolinska Hospital, Stockholm, Sweden
Collaborating institution: WHO HPV LabNet Global Reference Laboratory, Laboratory Medicine Skåne, Malmö, Sweden
Funding sources: None, except the routine health care services
Ethics: Approved by the Ethical Review Board of Stockholm AND in routine use in the private and public health services in the country
Condition: Cervical cancer precursor lesions.
Intervention(s): Human Papillomavirus (HPV)-based management of women with borderline (ASCUS) or mildly abnormal (CINI) cervical cytology has been extensively studied in the research setting. We wished to assess safety and healthcare resource use of a real-life healthcare policy using HPV triaging. All 15 outpatient clinics involved in the organized population-based screening program in Stockholm, Sweden screening program were randomized to either continue with prior policy (colposcopy of all women with ASCUS/CINI) or to implement a policy with HPV triaging and colposcopy only of HPV-positive women. The trial enrolled the 3319 women that were diagnosed with ASCUS (n=1335) or CINI (n=1984) in Stockholm during 17th March 2003 to 16th January 2006. Detection of high-grade cervical lesions (CINII+) and health care cost consumption was studied by registry linkages.
Trial start date: March 2003
Target population: All women resident in the county are covered by the organised program invitations. Attendance is about 75%.
Study type: Cluster randomisation, matched for catachment area population and outcome detection rate. Real-life study with no blinding.
Target sample size: 3 300 women. About 10 000 personyears.
Contact person for public inquiries: Lena Dillner
Controlled randomised implementation of colorectal cancer screening using FOBT in Finland among 60-69 year old men and women
Trial number: 002_2010_8_RHS
Lead researcher: Nea Malila
Primary institution: Finnish Cancer Registry
Funding sources: Municipal health budget, Cancer Society of Finland for planning and evaluation
Ethics: Public health services.
Condition: Colorectal cancer.
Intervention(s): Random allocation to screening (faecal occult blood testing biannually) or control groups during implementation period 2004-2014.
Trial start date: September 2004
Target population: Men and women aged 60-69 years.
Study type: Individually randomised public health policy.
Target sample size: 500 000 individuals in 2004.
Contact person for public inquiries: Liisa Rita
Comparison of vaginal HPV self-test and flexible appointment to reach long-term non-attending women in organized cervical screening
Trial number: 003_2013_1_RHS
Lead researcher: Lotten Darlin
Official scientific title:
Primary institution: Kvinnokliniken Skane University Hospital, University of Lund
Collaborating institution: Microbiology Skane University Hospital, University of Lund
Funding sources: Region Skane Sweden and Lund University, ALF
Ethics: Ethical Approval by Regional Ethical Board number Dnr2009/401
Condition: Cervical cancer prevention.
Trial start date: March 2011
Target population: Non-attendees to cervical cancer screening.
Study type: Randomized from the target population to either Self-sampling or invited to out-patient clinic examination.
Target sample size: 1 500 persons.
Contact person for public inquiries: Lotten Darlin
Comparison of use of vaginal HPV self-test and offering flexible appointments as strategies to reach long-term non-attending women in organized cervical screening.
Trial number: 004_2013_1_RHS
Lead researcher: Lotten Darlin
Primary institution: Kvinnokliniken Lund; University Hospital of Skane
Collaborating institution: Mikrobiology Malmö; University Hospital of Skane
Funding sources: Lund University Alf-medel and Region Skane
Ethics: Etikgodkännande nr Regional ethical board Dnr 2009/401/
Condition: Cervical cancer.
Intervention(s): Many cervical cancers occur among women who have not attended cervical screening. Strategies to reach non-attending women may improve the effectiveness of cervical screening programs. Aim: To compare the responses among long-term non-attending women to either i) HPV-testing of a self-collected vaginal sample, or ii) cytological screening with a flexible no-fee appointment for sampling at an outpatient clinic. Methods: Among the 242,000 women aged 32-65 years in Southern Sweden, we identified 28,635 women who had not had any cervical smears taken for >9 years. We randomized 1000 women to invitation to HPV self-testing, and 500 women to flexible outpatient clinic appointments. Responding women received a questionnaire about their reasons for previous non-attendance.
Trial start date: April 2011
Target population: Among the 242,000 women aged 32-65 years in Southern Sweden, we identified 28,635 women who had not had any cervical smears taken for >9 years. We randomized 1000 women to invitation to HPV self-testing, and 500 women to flexible outpatient clinic appointments.
Study type: Randomized controlled study.
Target sample size: 1 500 women and 1 500 years.
Contact person for public inquiries: Lotten Darlin
Further information: Lotten.Darlin@med.lu.se
PEGOSS, The impact of low-volume versus standard volume bowel preparation on the participation in primary screening colonoscopy: a randomized health services (RHS), comparative effectiveness research study
Trial number: 005_2014_1_RHS
Lead researcher: Jaroslaw Regula, MD, Professor
Primary institution: The Medical Centre for Postgraduate Education, Warsaw, Poland
Collaborating institution: The Maria Skłodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
Funding sources: Foundation for Polish Science, Medical Centre for Postgraduate Education
Ethics: Interventions in routine use in public health services of the country.
Condition: Screening for colorectal cancer.
Intervention(s): Standard-volume vs low-volume bowel preparations for screening colonoscopy.
Trial start date: March 2014
Target population: Individuals aged 55-64 years, eligible for participation in colorectal cancer population based screening program.
Study type: Individual randomization.
Target sample size: 13 468 individuals.
Contact person for public inquiries: Jaroslaw Regula, MD, Professor
Further information: jregula@coi.waw.pl
Randomized Implementation and Evaluation of Changes in the Norwegian Cervical Cancer Screening Program
Trial number: 006_2014_10_RHS
Lead researcher: Ameli Trope
Primary institution: The Cancer Registry of Norway
Funding sources: The Cancer Registry of Norway
Ethics: The intervention will be in routine use through the public health services of Norway.
Condition: Cervical cancer, CIN3 and AIS detection.
Intervention(s): Screening by 5-year hrHPV or 3-year LBC .
Trial start date: February 2015
Target population: 400 000 women in 4 counties aged 34-69 years, 100 000 per year, will be randomized to receive either 5-year hrHPV testing or 3-year LBC over a 4-year enrollment period. Attendance to the Norwegian Cervical Cancer Program is approximately 80%. From this, we assume that 320 000 women will be screened, 160 000 by hrHPV testing and 160 000 by LBC, over a 4-year enrollment period.
Study type: Individually pseudo-randomized health policy, not blinded.
Target sample size: 400 000 women.
Contact person for public inquiries: Birgit Engesaeter
Polish Colonoscopy Screening Program: a randomized health services (RHS) study
Trial number: 007_2015_01_RHS
Lead researcher: Jaroslaw Regula, MD, Professor
Primary institution: The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
Collaborating institution: The Medical Centre for Postgraduate Education, Warsaw, Poland
Funding sources: Ministry of Health of Republic of Poland, the Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, the Medical Centre for Postgraduate Education, Foundation of Polish Science financed by EU structural funds, Innovative Economy Operational Programme 2007 – 2013, Polish Foundation of Gastroenterology.
Ethics: Interventions in routine use in public health services of the country
Condition: Screening for colorectal cancer.
Intervention(s): Immediate vs postponed (5 years) screening colonoscopy in people invited by letter.
Trial start date: July 2012
Target population: Individuals aged 55-64 years, eligible for participation in colorectal cancer population based screening program.
Study type: Individual randomization.
Target sample size: 5 400 000 individuals.
Contact person for public inquiries: Jaroslaw Regula, MD, Professor
Effectiveness of electronic quality assurance (e-Gastronet) in endoscopy screening for colorectal cancer – a randomized controlled health services study
Trial number: 008_2015_02_RHS
Lead researcher: Jaroslaw Regula, MD, Professor
Primary institution: The Maria Sklodowska-Curie Memorial Cancer Centre and Institute of Oncology, Warsaw, Poland
Collaborating institution: University of Oslo, Oso, Norway
Funding sources: Polish National Centre for Research and Development, as part of Polish – Norwegian Research Programme.
Ethics: Interventions in routine use in public health services of the countries.
Condition: Screening for colorectal cancer.
Intervention(s): Free choice of form of patient feedback (paper questionnaire, automated telephone response system or online questionnaire) to screening endoscopy.
Trial start date: September 2015
Target population: Individuals aged 50-64 years, eligible for participation in colorectal cancer population based screening program, providing mobile phone number for feedback purpose.
Study type: Individual randomization, stratified by age and gender.
Target sample size: 2 800 individuals.
Contact person for public inquiries: Marek Bugajski