Improving site selection in clinical studies: a standardised, objective, multistep method and first experience results.

Abstract:

INTRODUCTION:A considerable number of clinical studies experience delays, which result in increased duration and costs. In multicentre studies, patient recruitment is among the leading causes of delays. Poor site selection can result in low recruitment and bad data quality. Site selection is therefore crucial for study quality and completion, but currently no specific guidelines are available. MATERIAL AND METHODS:Selection of sites adequate to participate in a prospective multicentre cohort study was performed through an open call using a newly developed objective multistep approach. The method is based on use of a network, definition of objective criteria and a systematic screening process. ILLUSTRATIVE EXAMPLE OF THE METHOD AT WORK:Out of 266 interested sites, 24 were shortlisted and finally 12 sites were selected to participate in the study. The steps in the process included an open call through a network, use of selection questionnaires tailored to the study, evaluation of responses using objective criteria and scripted telephone interviews. At each step, the number of candidate sites was quickly reduced leaving only the most promising candidates. Recruitment and quality of data went according to expectations in spite of the contracting problems faced with some sites. CONCLUSION:The results of our first experience with a standardised and objective method of site selection are encouraging. The site selection method described here can serve as a guideline for other researchers performing multicentre studies. TRIAL REGISTRATION NUMBER:ClinicalTrials.gov: NCT02297581.

journal_name

BMJ Open

journal_title

BMJ open

authors

Hurtado-Chong A,Joeris A,Hess D,Blauth M

doi

10.1136/bmjopen-2016-014796

subject

Has Abstract

pub_date

2017-07-12 00:00:00

pages

e014796

issue

7

issn

2044-6055

pii

bmjopen-2016-014796

journal_volume

7

pub_type

杂志文章

相关文献

BMJ Open文献大全
  • Raised inflammatory markers as a predictor of one-year mortality: a cohort study in primary care in the UK using electronic health record data.

    abstract:OBJECTIVES:Identification of patients at increased mortality risk is important in the context of increasing multimorbidity and an ageing population, to help facilitate the planning and delivery of services. The aim of this study was to examine 1-year all-cause mortality in a cohort of primary care patients in whom infl...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2019-036027

    authors: Watson J,Whiting P,Salisbury C,Banks J,Hamilton W

    更新日期:2020-10-15 00:00:00

  • Multi-stakeholder perspectives of locally commissioned enhanced optometric services.

    abstract:OBJECTIVES:To explore views of all stakeholders (patients, optometrists, general practitioners (GPs), commissioners and ophthalmologists) regarding the operation of community-based enhanced optometric services. DESIGN:Qualitative study using mixed methods (patient satisfaction surveys, semi-structured telephone interv...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2016-011934

    authors: Baker H,Harper RA,Edgar DF,Lawrenson JG

    更新日期:2016-10-25 00:00:00

  • Social inequalities in low birthweight outcomes in Sri Lanka: evidence from the Demographic and Health Survey 2016.

    abstract:OBJECTIVE:To investigate social inequalities underlying low birthweight (LBW) outcomes in Sri Lanka. DESIGN:Cross-sectional study. SETTING:This study used the Sri Lanka Demographic and Health Survey 2016, the first such survey to cover the entire country since the Civil War ended in 2001. PARTICIPANTS:Birthweight da...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2020-037223

    authors: Abeywickrama G,S Padmadas S,Hinde A

    更新日期:2020-05-25 00:00:00

  • Using facilitator-receiver peer dyads matched according to socioeconomic status to promote behaviour change in overweight adolescents: a feasibility study.

    abstract:OBJECTIVE:To evaluate the feasibility of an innovative peer intervention promoting healthy eating and physical activity, which purposefully selected peer facilitators according to socioeconomic status to target less-advantaged overweight receivers. SETTING:Nine high schools, two middle schools. PARTICIPANTS:One hundr...

    journal_title:BMJ open

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1136/bmjopen-2017-019731

    authors: Saez L,Legrand K,Alleyrat C,Ramisasoa S,Langlois J,Muller L,Omorou AY,De Lavenne R,Kivits J,Lecomte E,Briançon S,PRALIMAP-INÈS Trial Group.

    更新日期:2018-06-22 00:00:00

  • Impact of screening on cervical cancer incidence in England: a time trend analysis.

    abstract:OBJECTIVES:To better model underlying trends in cervical cancer incidence so as to model past trends, to estimate the impact of cervical screening on cervical cancer rates at different ages and to obtain a counterfactual baseline under a no-screening scenario. DESIGN:Trend analysis of cancer registry data recorded bet...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2018-026292

    authors: Pesola F,Sasieni P

    更新日期:2019-01-24 00:00:00

  • Health policies on dialysis modality selection: a nationwide population cohort study.

    abstract:OBJECTIVES:In Taiwan, peritoneal dialysis (PD) and haemodialysis are fully accessible to patients with end-stage renal disease. However, the usage of PD is considered low in Taiwan. Since 2005, 4 major policies have been implemented by Taiwan's Ministry of Health and Welfare, namely a multidisciplinary predialysis care...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2016-013007

    authors: Lin YC,Lin YC,Kao CC,Chen HH,Hsu CC,Wu MS

    更新日期:2017-01-11 00:00:00

  • Experiences of women with cardiac disease in pregnancy: a systematic review and metasynthesis.

    abstract:OBJECTIVE:Cardiac disease in pregnancy is a leading cause of maternal death in high-income countries. Evidence-based guidelines to assist in planning and managing the healthcare of affected women is lacking. The objective of this research was to produce the first qualitative metasynthesis of the experiences of pregnant...

    journal_title:BMJ open

    pub_type: 杂志文章,meta分析

    doi:10.1136/bmjopen-2018-022755

    authors: Dawson AJ,Krastev Y,Parsonage WA,Peek M,Lust K,Sullivan EA

    更新日期:2018-09-28 00:00:00

  • Rubella virus infection and associated factors among pregnant women attending the antenatal care clinics of public hospitals in Hawassa City, Southern Ethiopia: a cross-sectional study.

    abstract:OBJECTIVE:To assess the seroprevalence of recent/acute and past exposure to rubella virus infection and associated risk factors among pregnant women. DESIGN:A hospital-based cross-sectional study. SETTING:The study was conducted in two public hospitals in Hawassa City, Southern Ethiopia. PARTICIPANTS:A total of 422 ...

    journal_title:BMJ open

    pub_type: 杂志文章,多中心研究

    doi:10.1136/bmjopen-2017-016824

    authors: Tamirat B,Hussen S,Shimelis T

    更新日期:2017-10-05 00:00:00

  • Physical activity-related injuries among university students: a multicentre cross-sectional study in China.

    abstract:OBJECTIVES:This study aimed to investigate the epidemiological characteristics and preliminarily explore possible risk factors of physical activity-related injury (PARI) occurrences among Chinese university students via a multicentre mixed survey. DESIGN:Cross-sectional study. PARTICIPANTS:A total of 4758 undergradua...

    journal_title:BMJ open

    pub_type: 杂志文章,多中心研究

    doi:10.1136/bmjopen-2018-021845

    authors: Gao Y,Cai W,Gao L,Wang J,Liang J,Kwok H,Jia C,Li L

    更新日期:2018-09-21 00:00:00

  • Impact of community-based chronic obstructive pulmonary disease service, a multidisciplinary intervention in an area of high deprivation: a longitudinal matched controlled study.

    abstract:OBJECTIVE:To examine the effects of a consultant-led, community-based chronic obstructive pulmonary disease (COPD) service, based in a highly deprived area on emergency hospital admissions. DESIGN:A longitudinal matched controlled study using difference-in-differences analysis to compare the change in outcomes in the ...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2019-032931

    authors: Saini P,Rose T,Downing J,Matata B,Pilsworth S,Pemberton A,Comerford T,Wilson K,Shaw M,Harper LM,Daras K,Barr B

    更新日期:2020-05-27 00:00:00

  • Weight loss surgery for obstructive sleep apnoea with obesity in adults: a systematic review and meta-analysis protocol.

    abstract:INTRODUCTION:Obstructive sleep apnoea (OSA) is caused by complete or partial obstruction of the upper airway resulting in repeated episodes of interrupted or shallow breaths. OSA is associated with significant morbidity and mortality. The prevalence is estimated to range from 3% to 7% in the general population but may ...

    journal_title:BMJ open

    pub_type: 杂志文章,meta分析

    doi:10.1136/bmjopen-2017-020876

    authors: Dong Z,Hong BY,Yu AM,Cathey J,Shariful Islam SM,Wang C

    更新日期:2018-08-29 00:00:00

  • Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey.

    abstract:INTRODUCTION:Pain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability o...

    journal_title:BMJ open

    pub_type: 杂志文章,评审

    doi:10.1136/bmjopen-2016-014904

    authors: Mazzei LG,Bergamaschi CC,Silva MT,Lopes LC

    更新日期:2017-09-27 00:00:00

  • Effectiveness of the e-Tabac Info Service application for smoking cessation: a pragmatic randomised controlled trial.

    abstract:OBJECTIVE:To compare the effectiveness of the mobile e-Tabac Info Service (e-TIS) application (app) for helping adult smokers quit smoking with current practices. DESIGN:Pragmatic randomised controlled trial with a 1-year follow-up (2017-2018). SETTING:France, population-wide level. PARTICIPANTS:2806 adult smokers w...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2020-039515

    authors: Affret A,Luc A,Baumann C,Bergman P,Le Faou AL,Pasquereau A,Arwidson P,Alla F,Cambon L

    更新日期:2020-10-27 00:00:00

  • Is there a social gradient of sarcopenia? A meta-analysis and systematic review protocol.

    abstract:INTRODUCTION:Sarcopenia (or loss of muscle mass and function) is a relatively new area within the field of musculoskeletal research and medicine. Investigating whether there is a social gradient, including occupation type and income level, of sarcopenia, as observed for other diseases, will contribute significantly to ...

    journal_title:BMJ open

    pub_type: 杂志文章,meta分析

    doi:10.1136/bmjopen-2017-019088

    authors: Green D,Duque G,Fredman N,Rizvi A,Brennan-Olsen SL

    更新日期:2018-01-13 00:00:00

  • Facilitators and barriers to quality of care in maternal, newborn and child health: a global situational analysis through metareview.

    abstract:OBJECTIVE:Conduct a global situational analysis to identify the current facilitators and barriers to improving quality of care (QoC) for pregnant women, newborns and children. STUDY DESIGN:Metareview of published and unpublished systematic reviews and meta-analyses conducted between January 2000 and March 2013 in any ...

    journal_title:BMJ open

    pub_type: 杂志文章,meta分析,评审

    doi:10.1136/bmjopen-2013-004749

    authors: Nair M,Yoshida S,Lambrechts T,Boschi-Pinto C,Bose K,Mason EM,Mathai M

    更新日期:2014-05-22 00:00:00

  • Impact of the SIGN head injury guidelines and NHS 4-hour emergency target on hospital admissions for head injury in Scotland: an interrupted times series.

    abstract:OBJECTIVES:Head injury is a common reason for emergency department (ED) attendance. Around 1% of patients have life-threatening injuries, while 80% of patients are discharged. National guidelines (Scottish Intercollegiate Guidelines Network (SIGN)) were introduced in Scotland with the aim of achieving early identificat...

    journal_title:BMJ open

    pub_type: 杂志文章,多中心研究

    doi:10.1136/bmjopen-2018-022279

    authors: Marincowitz C,Lecky FE,Morris E,Allgar V,Sheldon TA

    更新日期:2018-12-22 00:00:00

  • Early intervention with tiotropium in Chinese patients with GOLD stages I-II chronic obstructive pulmonary disease (Tie-COPD): study protocol for a multicentre, double-blinded, randomised, controlled trial.

    abstract:INTRODUCTION:Owing to the high and increasing morbidity and mortality, chronic obstructive pulmonary disease (COPD) has become a major public health problem worldwide. Although the majority of patients with COPD are in the early stages, little attention has been paid to them, in particular regarding to early interventi...

    journal_title:BMJ open

    pub_type: 杂志文章,多中心研究,随机对照试验

    doi:10.1136/bmjopen-2013-003991

    authors: Li X,Zhou Y,Chen S,Zheng J,Zhong N,Ran P

    更新日期:2014-02-18 00:00:00

  • Development and validation of a prediction model for gestational hypertension in a Ghanaian cohort.

    abstract:OBJECTIVE:To develop and validate a prediction model for identifying women at increased risk of developing gestational hypertension (GH) in Ghana. DESIGN:A prospective study. We used frequencies for descriptive analysis, χ2 test for associations and logistic regression to derive the prediction model. Discrimination wa...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2016-012670

    authors: Antwi E,Groenwold RH,Browne JL,Franx A,Agyepong IA,Koram KA,Klipstein-Grobusch K,Grobbee DE

    更新日期:2017-01-16 00:00:00

  • Randomised controlled trial of a person-centred transition programme for adolescents with type 1 diabetes (STEPSTONES-DIAB): a study protocol.

    abstract:INTRODUCTION:Adolescence is a critical period for youths with chronic conditions, when they are supposed to take over the responsibility for their health. Type 1 diabetes (T1D) is one of the most common chronic conditions in childhood and inadequate self-management increases the risk of short-term and long-term complic...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2019-036496

    authors: Brorsson AL,Bratt EL,Moons P,Ek A,Jelleryd E,Torbjörnsdotter T,Sparud-Lundin C

    更新日期:2020-04-14 00:00:00

  • Cybersecurity features of digital medical devices: an analysis of FDA product summaries.

    abstract:OBJECTIVES:To more clearly define the landscape of digital medical devices subject to US Food and Drug Administration (FDA) oversight, this analysis leverages publicly available regulatory documents to characterise the prevalence and trends of software and cybersecurity features in regulated medical devices. DESIGN:We...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2018-025374

    authors: Stern AD,Gordon WJ,Landman AB,Kramer DB

    更新日期:2019-06-28 00:00:00

  • Relationship between socioeconomic status and type 2 diabetes: results from Korea National Health and Nutrition Examination Survey (KNHANES) 2010-2012.

    abstract:OBJECTIVE:To examine the relationship between socioeconomic status (SES) and type 2 diabetes using the Korea National Health and Nutrition Examination Survey (KNHANES) 2010-2012. DESIGN:A pooled sample cross-sectional study. SETTING:A nationally representative population survey data. PARTICIPANTS:A total of 14,330 i...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2014-005710

    authors: Hwang J,Shon C

    更新日期:2014-08-19 00:00:00

  • Interfacility transfer of pregnant women using publicly funded emergency call centre-based ambulance services: a cross-sectional analysis of service logs from five states in India.

    abstract:OBJECTIVE:To estimate the proportion of interfacility transfers (IFTs) transported by '108' ambulances and to compare the characteristics of the IFTs and non-IFTs to understand the pattern of use of '108' services for pregnant women in India. DESIGN:A cross-sectional analysis of '108' ambulance records from five state...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2016-015077

    authors: Singh S,Doyle P,Campbell OM,Oakley L,Rao GR,Murthy G

    更新日期:2017-06-09 00:00:00

  • Active play exercise intervention in children with asthma: a PILOT STUDY.

    abstract:OBJECTIVE:Increased physical activity (PA) may be beneficial for children with asthma. Knowledge about how to intervene and encourage children with asthma to be physically active is required. In the present study, we aimed to pilot a 6-week exercise intervention designed as active play and examine attendance rate, exer...

    journal_title:BMJ open

    pub_type: 临床试验,杂志文章

    doi:10.1136/bmjopen-2015-009721

    authors: Westergren T,Fegran L,Nilsen T,Haraldstad K,Kittang OB,Berntsen S

    更新日期:2016-01-05 00:00:00

  • Psychometric properties of the Breast Cancer Awareness Measurement among Chinese women: a cross-sectional study.

    abstract:OBJECTIVES:To perform the cross-cultural adaption of the Breast Cancer Awareness Measurement (BCAM) and to test its psychometric properties among Chinese women. DESIGN:This is a cross-sectional study. SETTINGS:This study was conducted in communities, schools and institutions in Changchun, Jilin Province, China. PART...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2019-035911

    authors: Liu N,Li P,Wang J,Chen DD,Sun WJ,Guo PP,Zhang XH,Zhang W

    更新日期:2020-03-09 00:00:00

  • Psychological distress and quality of life: rationale and protocol of a prospective cohort study in a rural district in Bangaladesh.

    abstract:INTRODUCTION:A significant proportion of the global burden of disease has been attributed to mental and behavioural disorders. People with mental disorders (MDs) have lower levels of health-related quality of life than those without MDs. Several studies have shown that in low-resource countries, a range of social deter...

    journal_title:BMJ open

    pub_type: 杂志文章,随机对照试验

    doi:10.1136/bmjopen-2017-016745

    authors: Uddin MN,Bhar S,Al Mahmud A,Islam FMA

    更新日期:2017-09-01 00:00:00

  • Levels of detection of hypertension in primary medical care and interventions to improve detection: a systematic review of the evidence since 2000.

    abstract:OBJECTIVES:In England, many hypertensives are not detected by primary medical care. Higher detection is associated with lower premature mortality. We aimed to summarise recent evidence on detection and interventions to improve detection in order to inform policies to improve care. DESIGN:Data sources: systematic revie...

    journal_title:BMJ open

    pub_type: 杂志文章,评审

    doi:10.1136/bmjopen-2017-019965

    authors: Baker R,Wilson A,Nockels K,Agarwal S,Modi P,Bankart J

    更新日期:2018-03-22 00:00:00

  • Public managers' role in creating workplace social capital (WSC) and its effect on employees' well-being and health: a protocol of a longitudinal cohort study (PUMA-WSC).

    abstract:INTRODUCTION:Workplace social capital (WSC) has been shown to affect employees' well-being and health, yet it is not clear how public managers can create WSC and which forms of WSC are most important. This study is the first prospective cohort study to examine the relationship between management behaviour, WSC, well-be...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2020-039027

    authors: Pihl-Thingvad S,Hansen SW,Winter V,Hansen MS,Willems J

    更新日期:2020-10-27 00:00:00

  • Unmet needs and opportunities for improving care for patients with advanced lung cancer on targeted therapies: a qualitative study.

    abstract:OBJECTIVE:Lung cancer is increasingly recognised as a heterogeneous disease. Recent advances with targeted therapies for lung cancer with oncogenic mutations have greatly improved the prognosis for this subset of patients, yet little is known about their experiences. This study aimed to identify the needs and explore t...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2019-032639

    authors: Al Achkar M,Marchand L,Thompson M,Chow LQM,Revere D,Baldwin LM

    更新日期:2020-03-23 00:00:00

  • Are sweet snacks more sensitive to price increases than sugar-sweetened beverages: analysis of British food purchase data.

    abstract:OBJECTIVES:Taxing sugar-sweetened beverages (SSBs) is now advocated, and implemented, in many countries as a measure to reduce the purchase and consumption of sugar to tackle obesity. To date, there has been little consideration of the potential impact that such a measure could have if extended to other sweet foods, su...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2017-019788

    authors: Smith RD,Cornelsen L,Quirmbach D,Jebb SA,Marteau TM

    更新日期:2018-04-26 00:00:00

  • Associations between sleep quality and its domains and insufficient physical activity in a large sample of Croatian young adults: a cross-sectional study.

    abstract:OBJECTIVES:The main purpose of the present study was to explore the associations between sleep quality and insufficient physical activity. DESIGN:Cross-sectional. SETTING:Faculties in Croatia. PARTICIPANTS:2100 university students (1049 men and 1051 women) aged 18-24 years were recruited. PRIMARY OUTCOME:To assess ...

    journal_title:BMJ open

    pub_type: 杂志文章

    doi:10.1136/bmjopen-2018-021902

    authors: Štefan L,Sporiš G,Krističević T,Knjaz D

    更新日期:2018-07-13 00:00:00