Our aim is to develop a Framework of Measurement for people living with Long COVID and their caregivers for use in Long COVID research and clinical practice. Specifically, we will characterise evidence pertaining to outcome measurement and identify implementation considerations for use of outcome measures among adults and children living with Long COVID and their caregivers.
We will conduct a scoping study involving: (1) an evidence review and (2) a two-phased consultation, using methodological steps outlined by the Arksey and O’Malley Framework and Joanna Briggs Institute. We will answer the following question: What is known about outcome measures used to describe, evaluate or predict health outcomes among adults and children living with Long COVID and their caregivers? Evidence review: we will review peer review published and grey literature to identify existing outcome measures and their reported measurement properties with people living with Long COVID and their caregivers. We will search databases including MEDLINE, Embase, CINAHL, PsycINFO and Scopus for articles published since 2020. Two authors will independently review titles and abstracts, followed by full text to select articles that discuss or use outcome measures for Long COVID health outcomes, pertain to adults or children living with Long COVID and/or their caregivers and are based in research or clinical settings. We will extract data including article characteristics, terminology and definition of Long COVID, health outcomes assessed, characteristics of outcome measures, measurement properties and implementation considerations. We will collate and summarise data to establish a preliminary Framework of Measurement. Consultation phase 1: we will conduct an environmental scan involving a cross-sectional web-based questionnaire among individuals with experience using or completing outcome measures for Long COVID, to identify outcome measures not found in the evidence review and explore implementation considerations for outcome measurement in the context of Long COVID. Consultation phase 2: we will conduct focus groups to review the preliminary Framework of Measurement and to highlight implementation considerations for outcome measurement in Long COVID. We will analyse questionnaire and focus group data using descriptive and content analytical approaches. We will refine the Framework of Measurement based on the focus group consultation using community-engaged approaches with the research team.
Protocol approved by the University of Toronto Health Sciences Research Ethics Board (protocol #46503) for the consultation phases of the study. Outcomes will include a Framework of Measurement, to enhance measurement of health outcomes in Long COVID research and clinical practice. Knowledge translation will also occur in the form of publications and presentations.
To understand and compare women’s antenatal and postnatal views on: (1) priorities for information provided about labour and delivery and (2) decision-making in labour and delivery.
Qualitative interview study using repeat interviews at two time points: during pregnancy (≥13 weeks gestation); and after birth (≥6 weeks).
Large maternity hospital in the Southwest of England.
Pregnant women accessing antenatal care were purposively sampled and recruited antenatally by community midwives to ensure representation from different sociodemographic groups, with diverse experiences of low and high-risk care.
Telephone interviews with a single researcher using a semistructured interview topic guide.
Interviews were audio recorded, transcribed verbatim, and qualitative thematic analysis was conducted using Braun and Clarke’s six-stage process.
Twelve women participated (12 antenatal interviews; 10 follow-up postnatal interviews). Overall, women’s postnatal views were consistent with their antenatal views about what they wanted to know and the factors that influence decision-making. Three themes were generated. Theme 1 ‘Sources of information’ presents evidence of how women obtain and use information (sub-themes: ‘social influences’, ‘patient responsibility for information seeking’, ‘NHS vs non-NHS resources’). Theme 2 reports women’s views and experiences of ‘The influence of Healthcare Professionals in decision-making’ (sub-themes ‘patient and professional roles in decision-making’, ‘conflicting advice and preferences’, ‘taking authority in emergency decision-making’). The final theme, theme 3, ‘When, how, and what information women want’ shows women want time to process information (sub-themes ‘when: it’s definitely information and time’, ‘how: presentation of information’, ‘what: information required’). Cross-cutting all themes, we found an unmet need for information to be tailored to the individual.
Women understand decision-making during labour and birth is a dynamic process. Women can struggle with the volume, quality and timing of information available. In busy maternity settings, the challenge is to better equip women with the information they want, and health professionals with the information they need to provide for personalised care and shared decision-making. Antenatal interventions that warrant further research include decision aids, birth plans, and structured counselling using core information sets. Insights from both antenatal and postnatal perspectives will help inform their development.
Patient activation (PAct)—a measure assessing an individual’s perceived knowledge, skills and confidence in managing their health and well-being—is often used to personalise and evaluate care, although its causal link to self-management behaviours (SMBs) and clinical outcomes remains uncertain. We aimed to synthesise the evidence on the causal association between PAct, SMBs and clinical outcomes in type 2 diabetes (T2D).
Systematic review and narrative synthesis of data summarised in a harvest plot.
We searched Medline, Embase, CENTRAL, PsycInfo, Web of Science and CINAHL up to April 2024 for relevant English articles.
We included studies of any quantitative design that reported on the association of PAct with clinical outcomes or SMBs in adult patients with T2D.
Two independent reviewers were involved, and any disagreements were discussed and resolved collaboratively. Risk-of-bias (RoB) was assessed using an adapted RoB Assessment Tool for Nonrandomised Studies. Levels of evidence were evaluated for each T2D-related outcome.
We identified 21 studies published between 2009 and 2023, including 15 cross-sectional studies and no randomised controlled trials. Eleven studies were conducted in the USA. Seventeen studies used the Patient Activation Measure questionnaire. There is moderate evidence that higher PAct scores are associated with better glycated haemoglobin levels (studies reporting on this association, n=14). There is very limited evidence that PAct improves diet (n=5) and physical activity (n=6). All other clinical outcomes and SMBs had inconclusive results due to either inconsistent or insufficient evidence, or both.
A causal relationship between PAct, clinical outcomes and SMBs in T2D cannot be established due to inconsistent evidence and a lack of high-quality studies. Thus, the use of PAct scores as a tailoring tool and an outcome measure in healthcare services requires further evaluation.
CRD42021230727.
Chronic non-cancer pain presents a global health problem, with a significant increase in opioid prescriptions over recent decades. However, opioid therapy poses risks of adverse events, overdose and non-medical use. As a result, many patients seek to discontinue or reduce their opioid intake. Strategies for opioid tapering often lack efficacy, prompting the investigation of novel approaches like open-label placebo (OLP), that is, the administration of a placebo with full disclosure that it is a placebo. OLP has shown efficacy in chronic non-cancer pain syndromes and has been suggested as a promising candidate for medication tapering. This study aims to assess whether OLPs can enhance the reduction of daily morphine equivalent dose (MED) in chronic non-cancer pain patients and examines its potential in mitigating opioid withdrawal symptoms.
This study is designed as a randomised, controlled, single-centre trial. Participants will be randomised into either an OLP group or a control group. The study duration will span six to nine weeks, during which all participants will aim to reduce their opioid intake. Both groups will monitor their opioid intake daily using a diary app and will receive feedback on their progress of reducing opioids. Additionally, participants in the OLP group will receive OLP tablets for the entire study period. During the first week, the OLP group will undergo a one week learning phase using a classical conditioning paradigm, where each opioid intake is paired with a placebo. In the subsequent five weeks, the OLP group will enter a dose-extension phase in which only the first opioid intake of the day is paired with a placebo, and additional placebos can be taken as desired. At the end of the study, qualitative interviews will be conducted with the first 15 participants in the OLP group. The primary outcome measure is daily opioid intake. Secondary outcomes include opioid withdrawal symptoms, pain severity, disability, anxiety, depression, opioid beliefs, intervention expectancy and qualitative data. Statistical analyses will include analysis of covariance and regression models.
The ethics committee of the Canton of Zurich, Switzerland, approved the study (SNCTP-nr.: SNCTP000005853/BASEC nr.: 2023–02327).
Participants will be compensated with 100 Swiss Francs for their full participation in the study. Participants who will take part in the qualitative interview will be compensated with additional 15 Swiss Francs.
This study is registered at clinicaltrials.gov: NCT06350786.