Publications by authors named "Philip Pallmann"

Article Synopsis
  • The Obstetric Bleeding Study UK (OBS UK) is a randomized controlled trial aimed at addressing postpartum hemorrhage, initially developed in Wales, which has noted improved maternal outcomes but faces limitations in generalizability due to demographic homogeneity in the Welsh sample.* -
  • To enhance the diversity and inclusivity of the trial, maternity units across the UK were selected based on their representation of various ethnic and socioeconomic profiles, with a focus on ensuring results are applicable to a broader population.* -
  • An interactive dashboard was created using census data to visualize and compare the demographics of each participating maternity unit, confirming that the trial sites reflect the wider UK's ethnic and socioeconomic diversity, despite some inconsistencies in data availability across different locations.*
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Background: Procalcitonin (PCT) is a blood marker used to help diagnose bacterial infections and guide antibiotic treatment. PCT testing was widely used/adopted during the COVID-19 pandemic in the UK.

Objectives: Primary: to measure the difference in length of early (during first 7 days) antibiotic prescribing between patients with COVID-19 who did/did not have baseline PCT testing during the first wave of the pandemic.

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Purpose: Patients with urinary calculi undergo resource-intensive follow-up. Application of a PROM, Urinary Stones and Intervention Quality of Life (USIQoL), can potentially optimise current practices if it matches the outcomes of traditional follow-up. Our objective was to develop, and conduct, a preliminary validation of the USIQoL based prediction model to aid triage.

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Background: Four out of five people living with osteoarthritis (OA) also suffer with at least one other long-term health condition. The complex interaction between OA and multiple long-term conditions (MLTCs) can result in difficulties with self-care, restricted mobility, pain, anxiety, depression and reduced quality of life. The aim of the MulTI-domain Self-management in Older People wiTh OstEoarthritis and Multi-Morbidities (TIPTOE) trial is to evaluate the clinical and cost-effectiveness of the Living Well self-management support intervention, co-designed with people living with OA, integrated into usual care, in comparison to usual care alone.

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Introduction: Huntington's disease (HD) is an inherited neurodegenerative disease causing progressive cognitive and motor decline, largely due to basal ganglia (BG) atrophy. Rhythmic training offers promise as therapy to counteract BG-regulated deficits. We have developed HD-DRUM, a tablet-based app to enhance movement synchronisation skills and improve cognitive and motor abilities in people with HD.

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Background: Family group conferences (FGCs) in child welfare bring immediate and wider family members together to decide on the best way to meet a child's needs. Unlike professionally led meetings, the aim is for decisions to be made by or with family members. Qualitative and mixed-method research with FGC participants tends to show positive experiences: most participants feel their voices are heard; FGCs facilitate family-driven solutions and closer relationships-within families and with social workers.

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Article Synopsis
  • - A study evaluated the cost-effectiveness of using procalcitonin (PCT) testing to guide antibiotic decisions for COVID-19 patients in UK hospitals during the pandemic.
  • - Data from 11 NHS hospitals showed those tested with PCT had shorter hospital stays, reduced antibiotic use, and better quality-adjusted life years (QALYs) compared to those who were not tested.
  • - Results suggest that PCT testing is likely to be cost-effective for hospitalized COVID-19 patients, although there is some uncertainty regarding these findings.
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Article Synopsis
  • - The study aimed to understand the factors influencing antibiotic prescribing decisions for COVID-19 pneumonia patients during the initial pandemic phase, using interviews with clinicians across NHS trusts in England and Wales.
  • - Clinicians' antibiotic prescriptions were initially guided by fears of secondary bacterial infections, but as their experience with COVID-19 grew, they became more adept at identifying when antibiotics were necessary versus when they weren't.
  • - A model was created to illustrate the decision-making process, emphasizing the roles of clinician confidence, experience, senior support, and organizational context in improving antibiotic stewardship during the pandemic.
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Background: Huntington disease (HD) is a neurodegenerative condition that leads to progressive loss of cognitive-executive and motor functions, largely due to basal ganglia (BG) atrophy. Currently, there are no therapeutic interventions tailored to address executive and motor dysfunction in people with HD. Music-based interventions may aid executive abilities by compensating for impaired BG-reliant timing and rhythm generation using external rhythmic beats.

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In the UK, the Medicines and Healthcare products Regulatory Agency consulted on proposals "to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines". The purpose of the consultation was to help finalise the proposals and contribute to the drafting of secondary legislation. We discussed these proposals as members of the Trials Methodology Research Partnership Adaptive Designs Working Group, which is jointly funded by the Medical Research Council and the National Institute for Health and Care Research.

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Randomized controlled trials are the gold standard for measuring causal effects. However, they are often not always feasible, and causal treatment effects must be estimated from observational data. Observational studies do not allow robust conclusions about causal relationships unless statistical techniques account for the imbalance of pretreatment confounders across groups and key assumptions hold.

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In adaptive clinical trials, the conventional end-of-trial point estimate of a treatment effect is prone to bias, that is, a systematic tendency to deviate from its true value. As stated in recent FDA guidance on adaptive designs, it is desirable to report estimates of treatment effects that reduce or remove this bias. However, it may be unclear which of the available estimators are preferable, and their use remains rare in practice.

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Background: Individuals living with long COVID experience multiple, interacting and fluctuating symptoms which can have a dramatic impact on daily living. The aim of the Long Covid Personalised Self-managemenT support EvaluatioN (LISTEN) trial is to evaluate effects of the LISTEN co-designed self-management support intervention for non-hospitalised people living with long COVID on participation in routine activities, social participation, emotional well-being, quality of life, fatigue, and self-efficacy. Cost-effectiveness will also be evaluated, and a detailed process evaluation carried out to understand how LISTEN is implemented.

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel virus responsible for the coronavirus disease 2019 (COVID-19) pandemic. Although COVID-19 is a viral illness, many patients admitted to hospital are prescribed antibiotics, based on concerns that COVID-19 patients may experience secondary bacterial infections, and the assumption that they may respond well to antibiotic therapy. This has led to an increase in antibiotic use for some hospitalised patients at a time when accumulating antibiotic resistance is a major global threat to health.

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Recent FDA guidance on adaptive clinical trial designs defines bias as "a systematic tendency for the estimate of treatment effect to deviate from its true value," and states that it is desirable to obtain and report estimates of treatment effects that reduce or remove this bias. The conventional end-of-trial point estimates of the treatment effects are prone to bias in many adaptive designs, because they do not take into account the potential and realized trial adaptations. While much of the methodological developments on adaptive designs have tended to focus on control of type I error rates and power considerations, in contrast the question of biased estimation has received relatively less attention.

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Objectives: Current sepsis guidelines do not provide good risk stratification of subgroups in whom prompt IV antibiotics and fluid resuscitation might of benefit. We evaluated the utility of mid-regional pro-adrenomedullin (MR-proADM) in identification of patient subgroups at risk of requiring PICU or high-dependency unit (HDU) admission or fluid resuscitation.

Design: Secondary, nonprespecified analysis of prospectively collected dataset.

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Article Synopsis
  • Late-phase platform protocols, such as basket and master protocols, are more efficient than traditional two-arm trials but are underutilized; this study shares operational recommendations from successful implementations.* -
  • A meeting of UK clinical trial experts was held to discuss the practical challenges and operational aspects specific to running late-phase platform trials, leading to a set of guidance for trialists.* -
  • The recommendations cover all stages of a platform trial, emphasizing key areas like protocol development, funding, staffing, data management, and effective communication with participants and stakeholders.*
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