Defining usual care comparators when designing pragmatic trials of complex health interventions: a methodology review
DiscussionWhen deciding the content of a usual care arm, researchers need to understand the context in which a trial will be implemented and what the trial needs to achieve to address its aim and remain ethical. This is a complex decision-making process and trade-offs might need to be made. It also requires research and engagement with stakeholders, and therefore time and funding during the trial ’s design phase.Trial registrationPROSPERO CRD42022307324. (Source: Trials)
Source: Trials - February 12, 2024 Category: Research Source Type: clinical trials
Good Statistical Practice —development of tailored Good Clinical Practice training for statisticians
Statisticians are fundamental in ensuring clinical research, including clinical trials, are conducted with quality, transparency, reproducibility and integrity. Good Clinical Practice (GCP) is an international... (Source: Trials)
Source: Trials - February 10, 2024 Category: General Medicine Authors: Deborah D. Stocken, Helen Mossop, Emma Armstrong, Steff Lewis, Susan J. Dutton, Claire Peckitt, Carrol Gamble and Julia Brown Tags: Methodology Source Type: research
Rudi Kundini, Pamoja Kundini (RKPK): study protocol for a hybrid type 1 randomized effectiveness-implementation trial using data science and economic incentive strategies to strengthen the continuity of care among people living with HIV in Tanzania
Economic incentives can improve clinical outcomes among in-care people living with HIV (PLHIV), but evidence is limited for their effectiveness among out-of-care PLHIV or those at risk of disengagement. We pro... (Source: Trials)
Source: Trials - February 10, 2024 Category: General Medicine Authors: Jillian L. Kadota, Laura J. Packel, Matilda Mlowe, Nzovu Ulenga, Natalino Mwenda, Prosper F. Njau, William H. Dow, Jingshen Wang, Amon Sabasaba and Sandra I. McCoy Tags: Study protocol Source Type: research
Effectiveness of structured psycho-oncological counseling for relatives of lung cancer patients based on the CALM approach —study protocol of a randomized controlled trial
The high incidence combined with the high lethality and bad prognosis of lung cancer highlight the need for psycho-oncological care for both patients and their relatives. While psychological interventions for ... (Source: Trials)
Source: Trials - February 10, 2024 Category: General Medicine Authors: Julia Dusel, Karin Meng, Hanna Arnold, Antonia Rabe and Elisabeth Jentschke Tags: Study protocol Source Type: research
Zero Self-Harm app: a mobile phone application to reduce non-suicidal self-injury —study protocol for a randomized controlled trial
Non-suicidal self-injury (NSSI) is a growing healthcare problem. Individuals with NSSI have an increased risk of suicidality. Due to stigma, they may self-injure in secret, which means they might not seek help... (Source: Trials)
Source: Trials - February 10, 2024 Category: General Medicine Authors: Evelyn Guerrero, Kate Andreasson, Lene Larsen, Niels Buus, Jette Louise Skovgaard Larsen, Jesper Krogh, Rasmus Thastum, Lone Lindberg, Katrine Lindblad, Annette Erlangsen and Merete Nordentoft Tags: Study protocol Source Type: research
