12 research outputs found
Strategies to improve recruitment to randomised controlled trials
No full textBackground Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research. Objectives To quantify the effects of strategies to improve recruitment of participants to randomised controlled trials. Search strategy We searched the Cochrane Methodology Review Group Specialised Register - CMR (The Cochrane Library (online) Issue 1 2008) (searched 20 February 2008); MEDLINE, Ovid (1950 to date of search) (searched 06 May 2008); EMBASE, Ovid (1980 to date of search) (searched 16 May 2008); ERIC, CSA (1966 to date of search) (searched 19 March 2008); Science Citation Index Expanded, ISI Web of Science (1975 to date of search) (searched 19 March 2008); Social Sciences Citation Index, ISI Web of Science (1975 to date of search) (searched 19 March 2008); and National Research Register (online) (Issue 3 2007) (searched 03 September 2007); C2-SPECTR (searched 09 April 2008). We also searched PubMed (25 March 2008) to retrieve "related articles" for 15 studies included in a previous version of this review. Selection criteria Randomised and quasi-randomised controlled trials of methods to increase recruitment to randomised controlled trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. Studies aiming to increase response rates to questionnaires or trial retention, or which evaluated incentives and disincentives for clinicians to recruit patients were excluded. Data collection and analysis Data were extracted on the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used risk ratios and their 95% confidence intervals to describe the effects in individual trials, and assessed heterogeneity of these ratios between trials. Main results We identified 27 eligible trials with more than 26,604 participants. There were 24 studies involving interventions aimed directly at trial participants, while three evaluated interventions aimed at people recruiting participants. All studies were in health care. Some interventions were effective in increasing recruitment: telephone reminders to non-respondents (RR 2.66, 95% CI 1.37 to 5.18), use of opt-out, rather than opt-in, procedures for contacting potential trial participants (RR 1.39, 95% CI 1.06 to 1.84) and open designs where participants know which treatment they are receiving in the trial (RR 1.25, 95% CI 1.18 to 1.34). However, some of these strategies have disadvantages, which may limit their widespread use. For example, opt-out procedures are controversial and open designs are by definition unblinded. The effects of many other recruitment strategies are unclear; examples include the use of video to provide trial information to potential participants and modifying the training of recruiters. Many studies looked at recruitment to hypothetical trials and it is unclear how applicable these results are to real trials. Authors' conclusions Trialists can increase recruitment to their trials by using the strategies shown to be effective in this review: telephone reminders; use of opt-out, rather than opt-in; procedures for contacting potential trial participants and open designs. Some strategies (e. g. open trial designs) need to be considered carefully before use because they also have disadvantages. For example, opt-out procedures are controversial and open designs are by definition unblinded. This review is published as a Cochrane Review in the Cochrane Database of Systematic Reviews 2011, Issue 10. Cochrane Reviews are regularly updated as new evidence emerges and in response to comments and criticisms, and the Cochrane Database of Systematic Reviews should be consulted for the most recent version of the Review.</p
Time to act : The challenges of working during and after cancer, initiatives in research and practice
No full textPeer reviewe
A Randomised trial of nicotine assisted reduction to stop in pharmacies - The RedPharm Study
No full textBackground
Public policy and clinical treatment in tobacco addiction in the UK has focused on cessation: an abrupt attempt to stop all cigarettes. However, recent evidence suggests that allowing more gradual withdrawal from tobacco or even permanent partial substitution by nicotine replacement therapy (NRT) could lead to net benefits to public health. No jurisdiction has introduced smoking reduction programmes in normal clinical care and the best methods for their implementation is uncertain. Community pharmacists offering smoking cessation services in the UK are ideally placed to implement reduction programmes.
This pilot study aims therefore to examine the feasibility of implementing smoking reduction programme in pharmacies, and also to see if behavioural support and a longer treatment affect the success rate for cessation.
Design and methods
This is a 2 × 2 randomised factorial trial of behavioural support versus no support and short versus standard length reduction programme. The pharmacists will recruit 16 patients per pharmacy, 160 smokers altogether. Pharmacists will randomise each participant by sealed envelopes. In a standard supported programme, the pharmacist will give support for 34 weeks, inviting participants to set a treatment goal and providing advice on how to reduce cigarette use. Participants in the short programme will be given the same advice on how to reduce but will reduce smoking over four weeks. Participants in the no support arms will be given a leaflet that describes the reduction programmes in 4-week and 34-week format. All participants are encouraged to use of NRT to support the reduction. These processes will be measured by recording the number of recruited smokers; percentage of those who reduce and sustain their consumption to at least 50% of baseline value, and the proportion of people who attain 4 weeks abstinence and 6 months abstinence. Interviews will assess smokers' and pharmacists' views on the way the programme ran.
Discussion
This is a pilot study to assess the feasibility of offering smoking reduction programme within pharmacies that offer naturalistic setting to show population benefit from these programmes. Findings from this trial will inform the development of evidence-based treatment for smokers who want to reduce and best approaches to engage reluctant quitters onto the programm
Evaluation of different recruitment and randomisation methods in a trial of general practitioner-led interventions to increase physical activity : a randomised controlled feasibility study with factorial design
No full textBackground:
Interventions promoting physical activity by General Practitioners (GPs) lack a strong evidence base. Recruiting participants to trials in primary care is challenging. We investigated the feasibility of (i) delivering three interventions to promote physical activity in inactive participants and (ii) different methods of participant recruitment and randomised allocation.
Methods:
We recruited general practices from Devon, Bristol and Coventry. We used a 2-by-2 factorial design for participant recruitment and randomisation. Recruitment strategies were either opportunistic (approaching patients attending their GP surgery) or systematic (selecting patients from practice lists and approaching them by letter). Randomisation strategies were either individual or by practice cluster. Feasibility outcomes included time taken to recruit the target number of participants within each practice. Participants were randomly allocated to one of three interventions: (i) written advice (control); (ii) brief GP advice (written advice plus GP advice on physical activity), and (iii) brief GP advice plus a pedometer to self-monitor physical activity during the trial. Participants allocated to written advice or brief advice each received a sealed pedometer to record their physical activity, and were instructed not to unseal the pedometer before the scheduled day of data collection. Participant level outcomes were reported descriptively and included the mean number of pedometer steps over a 7-day period, and European Quality of Life (EuroQoL)-5 dimensions (EQ-5D) scores, recorded at 12 weeks’ follow-up.
Results:
We recruited 24 practices (12 using each recruitment method; 18 randomising by cluster, 6 randomising by individual participant), encompassing 131 participants. Opportunistic recruitment was associated with less time to target recruitment compared with systematic (mean difference (days) -54.9, 95% confidence interval (CI) -103.6; -6.2) but with greater loss to follow up (28.8% versus. 6.9%; mean difference 21.9% (95% CI 9.6%; 34.1%)). There were differences in the socio-demographic characteristics of participants according to recruitment method. There was no clear pattern of change in participant level outcomes from baseline to 12 weeks across the three arms.
Conclusions:
Delivering and trialling GP-led interventions to promote physical activity is feasible, but trial design influences time to participant recruitment, participant withdrawal, and possibly, the socio-demographic characteristics of participants
Antenatal and neonatal risk factors in very preterm children were associated with language difficulties at 9 years of age
No full textAbstract
Aim: This Finnish study compared language and reading abilities between schoolchildren born at a very low gestational age (VLGA) of <32 weeks and at term and analysed any associations between antenatal and neonatal risk factors and language skills in the VLGA group.
Methods: We prospectively followed 76 children born at a VLGA and 50 children born at term when they reached a mean age of 9.0 (8.1–10.0) years. They attended mainstream schools and had no severe neurosensory disabilities. Receptive language ability, rapid naming and word reading were evaluated using standardised tests.
Results: Children in the VLGA group had lower scores for receptive language abilities (median 55.0 vs. 57.0, p = 0.01) and word reading (mean 4.4 vs. 5.1, p = 0.03) than the children in the term group. In the VLGA group, foetal growth restriction was associated with lower scores for rapid naming, early intraventricular haemorrhage was associated with poor word reading and respiratory distress syndrome was associated with poor rapid naming (p < 0.05).
Conclusions: Schoolchildren born at a VLGA had more difficulties with receptive language abilities and word reading than children born at term. Foetal growth restriction and early neonatal morbidities were associated with language difficulties
Language, communication and literacy skills of nine-year-old children born very preterm
No full textAbstract
Studies have demonstrated improved survival rates for infants born very preterm. However, children born very preterm remain at increased risk of short- and long-term adverse outcomes including neurodevelopmental delay and language difficulties when compared to their term counterparts. This study aimed to find out whether language, communication and literacy skills of nine-year-old schoolers born at a very low gestational age (VLGA) differ from children born full-term. This study also examined whether perinatal factors are associated with language, communication and literacy skills in children born at a VLGA without severe neurodevelopmental impairments.
Receptive and expressive language skills were assessed using Token Test for Children and Rapid Automatised Naming Test. The view of parents on communication abilities was evaluated using Children’s Communication Checklist-2. Technical reading skills and reading accuracy, fluency, comprehension and spelling were assessed with Word Chain Test and subtests of YTTE and Lukilasse.
This study found that children born at a VLGA exhibited poorer skills in receptive language skills compared to their full-term peers. According to their parents, they also had more difficulties in communication. Further, they exhibited poorer performance in reading comprehension, technical reading and spelling. Fetal growth restriction associated with poorer rapid naming, reading fluency and spelling skills, intraventricular haemorrhage with decoding skills, respiratory distress syndrome with rapid naming and sepsis with communication skills. The present study also revealed that low level of mother's education associated with receptive language skills in VLGA children.
In conclusion, VLGA children had poorer language, communication and literacy outcomes in several subdomains. In addition to prematurity, poor fetal growth and early neonatal morbidities were associated with language, communication and literacy difficulties at nine years of age. Language-based skills form a basis for academic achievement. Language evaluation and intervention practices for children born very preterm should be designed to ensure they receive timely support. Original papers Heikkinen, M., Kallankari, H., Partanen, L., Korkalainen, N., Kaukola, T., & Yliherva, A. (2021). Children born before 32 weeks of gestation displayed impaired reading fluency, comprehension and spelling skills at 9 years of age. Acta Paediatrica, 110(2), 521–527. https://doi.org/10.1111/apa.15456 https://doi.org/10.1111/apa.15456 Self-archived version Taskila, H., Heikkinen, M., Yliherva, A., Välimaa, T., Hallman, M., Kaukola, T., & Kallankari, H. (2022). Antenatal and neonatal risk factors in very preterm children were associated with language difficulties at 9 years of age. Acta Paediatrica, 111(11), 2100–2107. https://doi.org/10.1111/apa.16501 https://doi.org/10.1111/apa.16501 Self-archived version Heikkinen, M., Kallankari, H., Yliherva, A., & Välimaa, T., (2025). Nine-year-old children born at a very low gestational age showed communication difficulties ─ the view of parents. Manuscript submitted for publication. Tiivistelmä
Hyvin ennenaikaisesti (< 32 raskausviikolla) syntyneiden lasten selviytyminen on parantunut, mutta heillä on edelleen merkittävä riski kehityksellisille haasteille, kuten kielenkehityksen vaikeuksille. Tämän tutkimuksen tavoitteena oli tarkastella, eroavatko yhdeksänvuotiaiden hyvin ennenaikaisesti syntyneiden ja täysiaikaisena syntyneiden koululaisten kielen, kommunikoinnin ja lukemisen ja kirjoittamisen taidot toisistaan. Lisäksi tutkittiin, mitkä perinataaliset tekijät ovat yhteydessä hyvin ennenaikaisesti syntyneiden lasten taitoihin.
Kielen ymmärtämisen taitoja arvioitiin Lasten Token-testillä ja tuottamista Nopean sarjallisen nimeämisen testillä. Kommunikoinnin taitojen seulontamenetelmänä käytettiin vanhempien täyttämää Lasten kommunikointitaitojen kyselyä. Luku- ja kirjoitustaitoja (tekninen lukutaito, lukemisen tarkkuus ja sujuvuus, luetun ymmärtäminen, oikeinkirjoitus) tutkittiin Sanaketjutestillä ja YTTE- ja Lukilasse-testien osatesteillä.
Tämä tutkimus osoitti, että hyvin ennenaikaisesti syntyneiden lasten kielen ymmärtämisen taidot olivat heikommat kuin täysiaikaisena syntyneiden verrokkilasten. Vanhempien arvion perusteella myös kommunikointitaidot olivat verrokkiryhmää heikommat. Lisäksi hyvin ennenaikaisesti syntyneillä lapsilla oli verrokkeja enemmän haasteita teknisessä lukutaidossa, luetun ymmärtämisessä ja oikeinkirjoituksessa. Sikiöaikainen kasvunhidastuma oli yhteydessä heikompiin nopean nimeämisen, lukemisen sujuvuuden ja oikeinkirjoituksen taitoihin. Aivokammioverenvuoto oli yhteydessä heikompaan tekniseen lukutaitoon, hengitysvaikeusoireyhtymä heikompaan nopean nimeämisen taitoon, sepsis heikompiin kommunikointitaitoihin ja äidin matala koulutustaso heikompiin kielen ymmärtämisen taitoihin hyvin ennenaikaisesti syntyneillä lapsilla.
Hyvin ennenaikaisesti syntyneillä lapsilla oli siis täysiaikaisena syntyneitä lapsia heikommat taidot useilla kielen, kommunikoinnin ja luku, - ja kirjoitustaidon osa-alueilla. Sikiöaikainen kasvunhidastuma ja tietyt vastasyntyneisyyskauden sairaudet olivat yhteydessä heikompiin kielellisiin taitoihin vielä yhdeksän vuoden iässä. Hyvin ennenaikaisesti syntyneiden kouluikäisten lasten arviointi- ja kuntoutuskäytänteitä tulisi kehittää, jotta he saisivat taitojensa kehittymiselle riittävän tuen. Osajulkaisut Heikkinen, M., Kallankari, H., Partanen, L., Korkalainen, N., Kaukola, T., & Yliherva, A. (2021). Children born before 32 weeks of gestation displayed impaired reading fluency, comprehension and spelling skills at 9 years of age. Acta Paediatrica, 110(2), 521–527. https://doi.org/10.1111/apa.15456 https://doi.org/10.1111/apa.15456 Rinnakkaistallennettu versio Taskila, H., Heikkinen, M., Yliherva, A., Välimaa, T., Hallman, M., Kaukola, T., & Kallankari, H. (2022). Antenatal and neonatal risk factors in very preterm children were associated with language difficulties at 9 years of age. Acta Paediatrica, 111(11), 2100–2107. https://doi.org/10.1111/apa.16501 https://doi.org/10.1111/apa.16501 Rinnakkaistallennettu versio Heikkinen, M., Kallankari, H., Yliherva, A., & Välimaa, T., (2025). Nine-year-old children born at a very low gestational age showed communication difficulties ─ the view of parents. Manuscript submitted for publication. Academic dissertation to be presented with the assent of the Doctoral Programme Committee of Human Sciences of the University of Oulu for public defence in the Oulun Puhelin auditorium (L5), Linnanmaa, on 26 September 2025, at 12 noonAbstract
Studies have demonstrated improved survival rates for infants born very preterm. However, children born very preterm remain at increased risk of short- and long-term adverse outcomes including neurodevelopmental delay and language difficulties when compared to their term counterparts. This study aimed to find out whether language, communication and literacy skills of nine-year-old schoolers born at a very low gestational age (VLGA) differ from children born full-term. This study also examined whether perinatal factors are associated with language, communication and literacy skills in children born at a VLGA without severe neurodevelopmental impairments.
Receptive and expressive language skills were assessed using Token Test for Children and Rapid Automatised Naming Test. The view of parents on communication abilities was evaluated using Children’s Communication Checklist-2. Technical reading skills and reading accuracy, fluency, comprehension and spelling were assessed with Word Chain Test and subtests of YTTE and Lukilasse.
This study found that children born at a VLGA exhibited poorer skills in receptive language skills compared to their full-term peers. According to their parents, they also had more difficulties in communication. Further, they exhibited poorer performance in reading comprehension, technical reading and spelling. Fetal growth restriction associated with poorer rapid naming, reading fluency and spelling skills, intraventricular haemorrhage with decoding skills, respiratory distress syndrome with rapid naming and sepsis with communication skills. The present study also revealed that low level of mother's education associated with receptive language skills in VLGA children.
In conclusion, VLGA children had poorer language, communication and literacy outcomes in several subdomains. In addition to prematurity, poor fetal growth and early neonatal morbidities were associated with language, communication and literacy difficulties at nine years of age. Language-based skills form a basis for academic achievement. Language evaluation and intervention practices for children born very preterm should be designed to ensure they receive timely support.Tiivistelmä
Hyvin ennenaikaisesti (< 32 raskausviikolla) syntyneiden lasten selviytyminen on parantunut, mutta heillä on edelleen merkittävä riski kehityksellisille haasteille, kuten kielenkehityksen vaikeuksille. Tämän tutkimuksen tavoitteena oli tarkastella, eroavatko yhdeksänvuotiaiden hyvin ennenaikaisesti syntyneiden ja täysiaikaisena syntyneiden koululaisten kielen, kommunikoinnin ja lukemisen ja kirjoittamisen taidot toisistaan. Lisäksi tutkittiin, mitkä perinataaliset tekijät ovat yhteydessä hyvin ennenaikaisesti syntyneiden lasten taitoihin.
Kielen ymmärtämisen taitoja arvioitiin Lasten Token-testillä ja tuottamista Nopean sarjallisen nimeämisen testillä. Kommunikoinnin taitojen seulontamenetelmänä käytettiin vanhempien täyttämää Lasten kommunikointitaitojen kyselyä. Luku- ja kirjoitustaitoja (tekninen lukutaito, lukemisen tarkkuus ja sujuvuus, luetun ymmärtäminen, oikeinkirjoitus) tutkittiin Sanaketjutestillä ja YTTE- ja Lukilasse-testien osatesteillä.
Tämä tutkimus osoitti, että hyvin ennenaikaisesti syntyneiden lasten kielen ymmärtämisen taidot olivat heikommat kuin täysiaikaisena syntyneiden verrokkilasten. Vanhempien arvion perusteella myös kommunikointitaidot olivat verrokkiryhmää heikommat. Lisäksi hyvin ennenaikaisesti syntyneillä lapsilla oli verrokkeja enemmän haasteita teknisessä lukutaidossa, luetun ymmärtämisessä ja oikeinkirjoituksessa. Sikiöaikainen kasvunhidastuma oli yhteydessä heikompiin nopean nimeämisen, lukemisen sujuvuuden ja oikeinkirjoituksen taitoihin. Aivokammioverenvuoto oli yhteydessä heikompaan tekniseen lukutaitoon, hengitysvaikeusoireyhtymä heikompaan nopean nimeämisen taitoon, sepsis heikompiin kommunikointitaitoihin ja äidin matala koulutustaso heikompiin kielen ymmärtämisen taitoihin hyvin ennenaikaisesti syntyneillä lapsilla.
Hyvin ennenaikaisesti syntyneillä lapsilla oli siis täysiaikaisena syntyneitä lapsia heikommat taidot useilla kielen, kommunikoinnin ja luku, - ja kirjoitustaidon osa-alueilla. Sikiöaikainen kasvunhidastuma ja tietyt vastasyntyneisyyskauden sairaudet olivat yhteydessä heikompiin kielellisiin taitoihin vielä yhdeksän vuoden iässä. Hyvin ennenaikaisesti syntyneiden kouluikäisten lasten arviointi- ja kuntoutuskäytänteitä tulisi kehittää, jotta he saisivat taitojensa kehittymiselle riittävän tuen
Strategies to improve recruitment to randomised trials
No full textBackground
Recruiting participants to trials can be extremely difficult. Identifying strategies that improve trial recruitment would benefit both trialists and health research.
Objectives
To quantify the effects of strategies for improving recruitment of participants to randomised trials. A secondary objective is to assess the evidence for the effect of the research setting (e.g. primary care versus secondary care) on recruitment.
Search methods
We searched the Cochrane Methodology Review Group Specialised Register (CMR) in the Cochrane Library (July 2012, searched 11 February 2015); MEDLINE and MEDLINE In Process (OVID) (1946 to 10 February 2015); Embase (OVID) (1996 to 2015 Week 06); Science Citation Index & Social Science Citation Index (ISI) (2009 to 11 February 2015) and ERIC (EBSCO) (2009 to 11 February 2015).
Selection criteria
Randomised and quasi-randomised trials of methods to increase recruitment to randomised trials. This includes non-healthcare studies and studies recruiting to hypothetical trials. We excluded studies aiming to increase response rates to questionnaires or trial retention and those evaluating incentives and disincentives for clinicians to recruit participants.
Data collection and analysis
We extracted data on: the method evaluated; country in which the study was carried out; nature of the population; nature of the study setting; nature of the study to be recruited into; randomisation or quasi-randomisation method; and numbers and proportions in each intervention group. We used a risk difference to estimate the absolute improvement and the 95% confidence interval (CI) to describe the effect in individual trials. We assessed heterogeneity between trial results. We used GRADE to judge the certainty we had in the evidence coming from each comparison.
Main results
We identified 68 eligible trials (24 new to this update) with more than 74,000 participants. There were 63 studies involving interventions aimed directly at trial participants, while five evaluated interventions aimed at people recruiting participants. All studies were in health care.
We found 72 comparisons, but just three are supported by high-certainty evidence according to GRADE.
1. Open trials rather than blinded, placebo trials. The absolute improvement was 10% (95% CI 7% to 13%).
2. Telephone reminders to people who do not respond to a postal invitation. The absolute improvement was 6% (95% CI 3% to 9%). This result applies to trials that have low underlying recruitment. We are less certain for trials that start out with moderately good recruitment (i.e. over 10%).
3. Using a particular, bespoke, user-testing approach to develop participant information leaflets. This method involved spending a lot of time working with the target population for recruitment to decide on the content, format and appearance of the participant information leaflet. This made little or no difference to recruitment: absolute improvement was 1% (95% CI −1% to 3%).
We had moderate-certainty evidence for eight other comparisons; our confidence was reduced for most of these because the results came from a single study. Three of the methods were changes to trial management, three were changes to how potential participants received information, one was aimed at recruiters, and the last was a test of financial incentives. All of these comparisons would benefit from other researchers replicating the evaluation. There were no evaluations in paediatric trials.
We had much less confidence in the other 61 comparisons because the studies had design flaws, were single studies, had very uncertain results or were hypothetical (mock) trials rather than real ones.
Authors' conclusions
The literature on interventions to improve recruitment to trials has plenty of variety but little depth. Only 3 of 72 comparisons are supported by high-certainty evidence according to GRADE: having an open trial and using telephone reminders to non-responders to postal interventions both increase recruitment; a specialised way of developing participant information leaflets had little or no effect. The methodology research community should improve the evidence base by replicating evaluations of existing strategies, rather than developing and testing new ones
Methods to improve recruitment to randomised controlled trials : Cochrane systematic review and meta-analysis
No full textPeer reviewe
Work ability of survivors of breast, prostate, and testicular cancer in Nordic countries: a NOCWO study
No full textIntroduction Cancer can cause adverse effects on survivors' work ability. We compared the self-assessed work ability of breast, testicular, and prostate cancer survivors to that of people without cancer. We also investigated the association of disease-related and socio-demographic factors and job-related resources (organizational climate, social support, and avoidance behavior) with work ability and looked at whether these associations were different for the survivors and reference subjects. Methods Working aged cancer patients diagnosed between 1997 and 2002 were identified from hospital or cancer registries in Denmark, Finland, Iceland, and Norway (Nordic Study on Cancer and Work). A cancer-free reference group was selected from population registries. We collected information on work ability and other factors from 1,490 employed survivors and 2,796 reference subjects via a questionnaire. Results The adjusted mean value of work ability was slightly lower among the breast and prostate cancer survivors compared to the cancer-free population. Co-morbidity, chemotherapy, low workplace support, and low organizational commitment were associated with reduced work ability. Avoidance behavior from supervisors or colleagues was only related to work ability among the cancer survivors. Conclusions and implications More attention should be paid to assisting cancer survivors in work life, particularly those who have chronic diseases or have undergone chemotherapy. Although most factors affecting the work ability of the survivors and reference subjects were the same, survivors' work ability seemed to be particularly sensitive to avoidance behavior. The results suggest that there is a need to improve communication at the workplace and develop supportive leadership practices in order to avoid isolating behavior towards cancer survivors
