An analysis of protocols and publications suggested that most discontinuations of clinical trials were not based on preplanned interim analyses or stopping rules.

OBJECTIVES: To investigate the frequency of interim analyses, stopping rules, and data safety and monitoring boards (DSMBs) in protocols of randomized controlled trials (RCTs); to examine these features across different reasons for trial discontinuation; and to identify discrepancies in reporting between protocols and publications. STUDY DESIGN AND SETTING: We used data from a cohort of RCT protocols approved between 2000 and 2003 by six research ethics committees in Switzerland, Germany, and Canada. RESULTS: Of 894 RCT protocols, 289 prespecified interim analyses (32.3%), 153 stopping rules (17.1%), and 257 DSMBs (28.7%). Overall, 249 of 894 RCTs (27.9%) were prematurely discontinued; mostly due to reasons such as poor recruitment, administrative reasons, or unexpected harm. Forty-six of 249 RCTs (18.4%) were discontinued due to early benefit or futility; of those, 37 (80.4%) were stopped outside a formal interim analysis or stopping rule. Of 515 published RCTs, there were discrepancies between protocols and publications for interim analyses (21.1%), stopping rules (14.4%), and DSMBs (19.6%). CONCLUSION: Two-thirds of RCT protocols did not consider interim analyses, stopping rules, or DSMBs. Most RCTs discontinued for early benefit or futility were stopped without a prespecified mechanism. When assessing trial manuscripts, journals should require access to the protocol.

Time-lapse -intervallikuvaaminen

Miltä sinusta tuntuisi nähdä vanhenevasi viisikymmentä vuotta minuutissa? Time-lapse -kuvaus on nykytekniikalla ainoa keino ihmisille matkustaa ajassa. Tällä kuvaustavalla on mahdollista hidastaa elämää tai vastaavasti nopeuttaa sitä. Tämän opinnäytetyön tarkoituksena on käydä läpi ne keinot ja tekniikat kuinka time-lapse -kuvia voidaan tehdä. Työn tavoitteena on ollut ymmärtää time-lapse -kuvaamista ja tutustua eri efekteihin, joita voi tehdä intervallikuvauksen avulla. Työhön on tehty kuvamateriaalia kirjallisen osan tueksi, jotta lukijan olisi mahdollisimman helppo ymmärtää kuvaustapaa. Työhön on tehty kaavoja ja kuvia, jotka antavat lukijalle mahdollisuuden myös kokeilla kuvien ottamista. Työssä on kerrottu kuvien ottamisesta ja siinä helposti tehtävistä virheistä, jotta lukijan ei tarvitsisi omissa kokeiluissaan ajaa samoihin ansoihin, kuin opinnäytetyötä tehdessä on ajettu. Time-lapse -kuvaaminen on kiehtova tapa tuoda kaikki valokuvauksen keinot elokuvaan. Tämä työ on tehty sitä varten, että tekijä itse on syventänyt ymmärrystään kuvaustapaan ja siksi, että lukija voisi suunnitella kuvauksiaan monipuolisemmin. Tämä työ käy time-lapse -kuvaamisen pinnalla. Syvemmällä kuvaustavan sisällä on miljoonia keinoja, joita on mahdollista löytää, kokeilla ja käyttää. Tämän työn tarkoituksena on olla alku matkalle, joka vie mukanaan kokeilemaan uusia keinoja, joita ei ehkä kuvien digitaalisuuden tuomien mahdollisuuksien myötä ole vielä edes löydetty.

Premature Discontinuation of Randomized Trials in Critical and Emergency Care: A Retrospective Cohort Study.

OBJECTIVES: Randomized clinical trials that enroll patients in critical or emergency care (acute care) setting are challenging because of narrow time windows for recruitment and the inability of many patients to provide informed consent. To assess the extent that recruitment challenges lead to randomized clinical trial discontinuation, we compared the discontinuation of acute care and nonacute care randomized clinical trials. DESIGN: Retrospective cohort of 894 randomized clinical trials approved by six institutional review boards in Switzerland, Germany, and Canada between 2000 and 2003. SETTING: Randomized clinical trials involving patients in an acute or nonacute care setting. SUBJECTS AND INTERVENTIONS: We recorded trial characteristics, self-reported trial discontinuation, and self-reported reasons for discontinuation from protocols, corresponding publications, institutional review board files, and a survey of investigators. MEASUREMENTS AND MAIN RESULTS: Of 894 randomized clinical trials, 64 (7%) were acute care randomized clinical trials (29 critical care and 35 emergency care). Compared with the 830 nonacute care randomized clinical trials, acute care randomized clinical trials were more frequently discontinued (28 of 64, 44% vs 221 of 830, 27%; p = 0.004). Slow recruitment was the most frequent reason for discontinuation, both in acute care (13 of 64, 20%) and in nonacute care randomized clinical trials (7 of 64, 11%). Logistic regression analyses suggested the acute care setting as an independent risk factor for randomized clinical trial discontinuation specifically as a result of slow recruitment (odds ratio, 4.00; 95% CI, 1.72-9.31) after adjusting for other established risk factors, including nonindustry sponsorship and small sample size. CONCLUSIONS: Acute care randomized clinical trials are more vulnerable to premature discontinuation than nonacute care randomized clinical trials and have an approximately four-fold higher risk of discontinuation due to slow recruitment. These results highlight the need for strategies to reliably prevent and resolve slow patient recruitment in randomized clinical trials conducted in the critical and emergency care setting.

Dikter

Edith Södergran (1892-1923) on lyyrisen ilmaisun uudistaja ja suomenruotsalaisen modernismin kärkihahmo. Sairaus ja aineellinen puute varjostivat Södergranin elämää; hän sairastui 16-vuotiaana keuhkotautiin, johon hän myöhemmin menehtyi. Södergran oli käynyt koulua Pietarissa ja matkustellut parantolahoidoissa Sveitsissä, josta teki myös matkan Italiaan. Viimeiset vuotensa hän asui äitinsä kanssa Kannaksen Raivolassa.

Södergranin moderni, feminiininen ja eroottinen runous heijastelee ajan ekspressionistisia ja symbolistisia virtauksia. Runot eivät noudatelleet mitään perinteisiä kaavoja. Esikoisteos Dikter sai ymmärtämättömän vastaanoton, eikä Södergrania eläessään juurikaan arvostettu. Nykyään Södergran on kuitenkin kansainvälisesti arvostetuimpia ja tunnetuimpia suomalaisia runoilijoita.

Bias in dissemination of clinical research findings: structured OPEN framework of what, who and why, based on literature review and expert consensus.

OBJECTIVE: The aim of this study is to review highly cited articles that focus on non-publication of studies, and to develop a consistent and comprehensive approach to defining (non-) dissemination of research findings. SETTING: We performed a scoping review of definitions of the term 'publication bias' in highly cited publications. PARTICIPANTS: Ideas and experiences of a core group of authors were collected in a draft document, which was complemented by the findings from our literature search. INTERVENTIONS: The draft document including findings from the literature search was circulated to an international group of experts and revised until no additional ideas emerged and consensus was reached. PRIMARY OUTCOMES: We propose a new approach to the comprehensive conceptualisation of (non-) dissemination of research. SECONDARY OUTCOMES: Our 'What, Who and Why?' approach includes issues that need to be considered when disseminating research findings (What?), the different players who should assume responsibility during the various stages of conducting a clinical trial and disseminating clinical trial documents (Who?), and motivations that might lead the various players to disseminate findings selectively, thereby introducing bias in the dissemination process (Why?). CONCLUSIONS: Our comprehensive framework of (non-) dissemination of research findings, based on the results of a scoping literature search and expert consensus will facilitate the development of future policies and guidelines regarding the multifaceted issue of selective publication, historically referred to as 'publication bias'.