Preferred labels and language to improve communication about lesions at low risk of progressing to cancer: qualitative interviews with patients and physicians

Objectives
We explored how to improve communication about low-risk lesions including labels, language and other strategies.

Design
Qualitative description and thematic analysis to examine the transcripts of telephone interviews with patients who had low-risk lesions and physicians; and mapping to Communication Accommodation Theory to interpret themes.

Setting
Canada

Participants
15 patients: 6 (40%) bladder, 5 (33%) prostate and 4 (27%) cervix lesions; and 13 physicians: 7 (54%) cervix, 3 (23%) bladder and 3 (23%) prostate lesions.

Main outcome measures
Patient and physician views of labels, language and other strategies to improve communication about low-risk lesions.

Results
Patients and clinicians held discordant views about low-risk lesion label impact, preferences and rationale. All labels prompted confusion and anxiety among patients. In contrast, physicians perceived that patients understood that labels they used across all label categories (abnormal, precursor-to-cancer and cancer) implied low risk for cancer progression. Patients preferred abnormal cells, particularly when first learning of their diagnosis, and desired additional information to distinguish their diagnosis from cancer and justify treatment. In contrast, physicians favoured precursor-to-cancer and cancer labels out of habit, to match labels that patients saw elsewhere (online, charts) and to convince patients to attend follow-up and treatment visits. However, patients and physicians largely agreed on the need for 16 strategies that could improve communication about low-risk lesions including language (eg, plain language, situate low-risk lesions on cancer spectrum) and complementary communication strategies (eg, longer appointments, visual aids, connect patients with support services or groups).

Conclusions
The findings build on prior research by revealing that modifying labels is not the only or best strategy needed to improve communication about low-risk lesions. Ongoing research should examine how best to implement the strategies recommended by patients and physicians.

Leggi
Gennaio 2025

Areas to Refine in the Skills to Manage Pain (STOMP) Trial

To the Editor In the randomized clinical trial evaluating the efficacy of the Skills to Manage Pain (STOMP) intervention for pain management, Jones et al provided evidence for the effectiveness of this approach for chronic pain among individuals living with HIV. However, we identified specific limitations in the study design that may have introduced bias into the research findings, warranting further discussion.

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Gennaio 2025

Areas to Refine in the Skills to Manage Pain (STOMP) Trial

To the Editor We appreciate the comprehensive and insightful study by Jones et al published recently in JAMA Internal Medicine. This randomized clinical trial highlighted the potential of the Skills to Manage Pain (STOMP) intervention in alleviating chronic pain among patients with HIV. We commend the authors for their contributions to this vital research and would like to discuss areas that warrant cautious interpretation and further exploration.

Leggi
Gennaio 2025

Areas to Refine in the Skills to Manage Pain (STOMP) Trial

To the Editor In the randomized clinical trial by Jones et al, the authors demonstrated the effectiveness of the Skills to Manage Pain (STOMP) intervention for patients with chronic pain and HIV, with its trial design providing valuable support for future studies. As social health care professionals, we affirm the success of this outcome; however, the understanding of these findings can be further enriched in terms of synergistic action between public health and social work professionals.

Leggi
Gennaio 2025

Areas to Refine in the Skills to Manage Pain (STOMP) Trial

To the Editor We read with interest the randomized clinical trial by Jones et al on the efficacy of the Skills to Manage Pain (STOMP) intervention for people with HIV experiencing chronic pain. This study provided valuable information on a novel behavioral approach for managing a challenging comorbidity in this population. However, we wish to highlight several important points that may warrant further exploration.

Leggi
Gennaio 2025

Areas to Refine in the Skills to Manage Pain (STOMP) Trial

In Reply We are excited that our randomized clinical trial of the Skills To Manage Pain (STOMP) intervention, an efficacious behavioral intervention for chronic pain tailored to people with HIV, generated substantial engagement from readers of JAMA Internal Medicine. We welcome the opportunity to discuss our study further, and herein, we respond to all 4 letters to the editor.

Leggi
Gennaio 2025

Efficacy of esketamine for chronic post-thoracotomy pain: protocol for a systematic review and meta-analysis

Introduction
Chronic post-thoracotomy pain (CPTP) is a persistent and disabling condition affecting a significant proportion of patients after thoracotomy and posing a challenge for clinicians, despite advances in surgical and pain management strategies. Esketamine, the S-enantiomer of ketamine, has emerged as a promising therapeutic agent for various pain conditions, with evidence for its effectiveness in alleviating acute and chronic pain. This systematic review and meta-analysis will be conducted to assess the efficacy of esketamine in treating CPTP, and evaluate its effectiveness in reducing pain intensity, improving functional outcomes, and reducing opioid consumption, as well as its adverse effects.

Methods and analysis
Computer-based literature retrieval in the PubMed, Embase, Web of Science, Cochrane Library, China National Knowledge Infrastructure (CNKI), Wanfang database and China Science and Technology Journal Database (VIP) for randomised controlled trials will be conducted from database inception to April 2024, with no restrictions on the language of publication. Eligible trials will be those focused on esketamine use to prevent and treat CPTP in adult patients; trial groups will have received esketamine and control groups will have been treated with placebo, standard treatment or other non-esketamine medications. Primary outcome measures can include the incidence of CPTP at 3 months, 6 months or 12 months postoperatively. Secondary outcome measures will encompass Visual Analogue Scale and Numerical Rating Scale Scores for rest and movement at different postoperative timepoints, the total number and effective number of patient-controlled analgesia button presses, total consumption of sufentanil, rate of rescue analgesia, and the occurrence of postoperative adverse reactions. Two researchers will independently screen the literature, evaluate its quality and extract the data. Meta-analysis will be performed on literature meeting the quality criteria using Review Manager V.5.3 software.

Ethics and dissemination
This review does not require ethical approval. On completion, the results of the review will be submitted to a peer-reviewed journal for publication and/or presented at an academic conference.

Trial registration number
PROSPERO, CRD42024526945.

Leggi
Dicembre 2024

DREAM: an adaptive, randomised, placebo-controlled trial of duloxetine for reducing leg pain in people with chronic sciatica–trial protocol

Introduction
Sciatica is a debilitating condition that often becomes chronic, and for which there are few effective treatment options. Treatments such as the anti-depressant duloxetine have shown promise, but the evidence is inconclusive. We are describing a high quality, definitive trial to investigate the efficacy, safety and cost-effectiveness of duloxetine in chronic sciatica.

Methods and analysis
The duloxetine for chronic sciatica (DREAM) trial is a randomised, superiority, parallel-group, placebo-controlled, triple-blinded (participant, clinician, assessor) trial with an adaptive group sequential design investigating the efficacy and safety of duloxetine in participants with chronic sciatica of at least 3 months duration. Participants will be randomised at a 1:1 ratio to duloxetine or placebo. 332 participants will be recruited on presentation to general practices, specialist clinics and hospital emergency departments or from hospital in-patient wards and from the community. In the active treatment group, participants will receive duloxetine 60 mg per day for 12 weeks, including 1 week of titration at 30 mg/day. The treatment phase will be followed by a 2-week tapering phase where they will receive duloxetine 30 mg/day. Participants will be followed-up for 1 year, with outcomes being measured 4, 8, 12, 16, 26, and 52 weeks post-randomisation. The primary outcome is leg pain intensity at 12 weeks post-randomisation. Secondary outcomes include back pain intensity, disability, time to recovery, quality of life, depressive and anxiety symptoms, and sleep disturbance. Adverse events will be recorded, and a cost-effectiveness analysis will be conducted.

Ethics and dissemination
Ethical approval has been granted by the University of Sydney Human Research Ethics Committee. Trial results will be disseminated by publications, conference presentations and via the media.

Trial registration number
ACTRN12624000919516.

Leggi
Dicembre 2024

Monitoring low-value care in medical patients from Swiss university hospitals using a Findable, Accessible, Interoperable, Reusable (FAIR) national data stream and patient and public involvement: LUCID study protocol

Introduction
Healthcare practices providing minimal or no benefit to recipients have been estimated to represent 20% of healthcare costs. However, defining, measuring and monitoring low-value care (LVC) and its downstream consequences remain a major challenge. The purpose of the National Data Stream (LUCID NDS) is to identify and monitor LVC in medical inpatients using routinely collected hospital data.

Methods and analysis
This protocol describes a multistep approach to the identification and surveillance of LVC: (1) creating an NDS based on Findable, Accessible, Interoperable, Reusable (FAIR) principles using routinely collected hospital data from medical inpatients who signed a general consent for data reuse from 2014 onwards; (2) selecting recommendations applicable to medical inpatients using data from LUCID NDS to develop a comprehensive and robust set of LVC indicators; (3) establishing expert consensus on the most relevant and actionable recommendations to prevent LVC; (4) applying the Strength of Recommendation Taxonomy methodology to assess the level of evidence of recommendations; (5) involving patients and the public at various stages of LUCID NDS; and (6) designing monitoring rules within the LUCID NDS and validating quality measures.

Ethics and dissemination
The ethics committees of all five participating university hospitals (Basel, Bern, Geneva, Lausanne and Zurich) approved LUCID NDS as a national registry on quality of care. We will disseminate our findings in peer-reviewed journals, at professional conferences, and through short reports sent to participating entities and stakeholders; moreover, lay summaries are provided for patients and the broader public on our webpage (www.LUCID-nds.ch).

Leggi
Dicembre 2024

Co-designing a low-intensity psychological therapy for fear of recurrence in psychosis using translational learning from fear of recurrence in oncology: protocol for intervention development for future testing in a feasibility study

Introduction
Fear of recurrence is a transdiagnostic problem experienced by people with psychosis, which is associated with anxiety, depression and risk of future relapse events. Despite this, there is a lack of available psychological interventions for fear of recurrence, and psychological therapies for schizophrenia are often poorly implemented in general. However, low-intensity psychological therapy is available for people who experience fear of recurrence in the context of cancer, which means there is an opportunity to learn what has worked in a well-implemented psychological therapy to see if any learning can be adapted for schizophrenia care. This article describes the design, methods and expected data collection of development, acceptability, feasibility, and preliminary outcome signals for a coproduced low-intensity psychological intervention targeting fear of relapse in people with schizophrenia (INDIGO), which aims to develop an acceptable psychological intervention for fear of recurrence.

Methods and analysis
INDIGO will use a mixed-methods approach to co-design and deliver a model and treatment pathway for a psychological intervention for people diagnosed with schizophrenia who experience fear of recurrence. The study will consist of four stages. First, in-depth interviews with mental health staff and people diagnosed with schizophrenia (with a further social network mapping task for patient participants only) to develop the intervention. Second, in-depth interviews with people who have accessed the Glasgow Fear of Recurrence service and oncology staff will be conducted to inform further development of the intervention. Third, co-design workshops will be held with people diagnosed with schizophrenia and mental health staff to co-design intervention content and the treatment pathway. Finally, people diagnosed with schizophrenia will be presented with an intervention prototype and invited to complete ‘think-aloud’ interviews to gather further feedback so adaptations can be implemented.

Ethics and dissemination
The INDIGO study received ethical approval from East Midlands—Nottingham 2 Research Ethics Committee (24/EM/0124). The study received independent peer review prior to funding. This co-design study is expected to lead to a future feasibility study and, if indicated, a randomised controlled trial.

Leggi
Dicembre 2024

Postnatal foot length measurement as a proxy to identify low birth weight for frontline health workers in rural Sindh Province, Pakistan: a diagnostic accuracy study

Objective
To assess the diagnostic accuracy of postnatal foot length (FL) measurements as a proxy to identify low birth weight (LBW) for frontline healthcare workers in rural Sindh Province, Pakistan.

Design
A community-based cross-sectional study.

Setting
This study was conducted in the catchment area of Global Network’s Maternal and Newborn Health Registry, Thatta, Sindh Province, Pakistan, from January to June 2023.

Participants
Singleton live births irrespective of gestational age at birth.

Reference standard
Birth weight was measured using calibrated digital weighing scales in grams based on the average of three readings with minimal clothing.

Index test
FL was measured within 48 hours of birth using a rigid transparent plastic ruler in centimetres based on the average of three measurements.

Primary outcome
Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), receiver operating characteristics curve and area under the curve with 95% CI were calculated. Euclidean distance was used to identify the cutoff of FL to identify LBW. A simple linear equation was created to predict the birth weight.

Results
Out of 336 analysed newborns, 179 (53.3%) were male and 157 (46.7%) were female. The median birth weight was 2801 g (IQR: 2465–3057), of whom 88 (26.2%) were LBW. The median foot length was 7.9 cm (IQR: 7.6–8.1). For identifying LBW, the foot length cutoff was ≤7.6 cm with 90.3% sensitivity, 81.8% specificity, 63.8% PPV and 96.0% NPV. A FL of 7.6 cm predicted birth weight of 2459.4 g.

Conclusion
Postnatal FL cutoff of ≤7.6 cm has adequate predictive value served as a simple, low-cost and reliable method to identify LBW for frontline healthcare providers in the rural settings of Thatta without calibrated weighing scales to triage LBW newborns in need of higher-level care.

Trial registration number
NCT05515211.

Leggi
Dicembre 2024

Low-added sugar dietary intervention study to mitigate glucose intolerance and improve body composition in adults with cystic fibrosis: a protocol of a double-blind, randomised study

Introduction
People with cystic fibrosis (PwCF) are at high risk for developing cystic fibrosis (CF)-related diabetes (CFRD), which worsens morbidity and mortality. Although the pathological events leading to the development of CFRD are complex and not completely understood, dietary factors may play a role. For example, habitual intake of dietary added sugar (i.e., sugar not naturally occurring in foods) has been shown to be increased in PwCF and this excess intake of added sugar could increase the risk of CFRD.

Methods and analysis/design
The goal of this ongoing double-blind, randomised, parallel-group clinical trial is to recruit approximately 60 clinically stable adults with CF to determine if a low-added sugar intervention improves beta-cell responsiveness and insulin sensitivity (Aim 1), reduces visceral adipose tissue (VAT) and other ectopic fat deposition (Aim 2) and improves plasma redox status (Aim 3) over 8 weeks compared with a typical CF diet. All foods will be provided. Participant selection criteria include confirmed CF diagnosis without CFRD, ≥18 years of age, and baseline estimated daily total added sugar intake >16 tsp. Eligible participants will be randomised to one of two arms: a low-added sugar diet (

Leggi
Dicembre 2024

Living with pain and Parkinsons developing an understanding of the impact, trajectory and pain management needs: a qualitative interview study protocol

Introduction
Pain is reported as one of the most troubling symptoms for people with Parkinson’s (PwP); however, the literature exploring their lived experience of pain and how to manage it is limited. Pain affects PwP at all stages of their condition and can fluctuate and change over time. Therefore, it is pertinent to speak to PwP to understand their experiences of pain to inform the development of tailored behavioural interventions to manage pain. How pain interacts with other Parkinson’s symptoms lacks consensus. Gaining a better understanding of this from the perspective of PwP is important to inform interventions. Exploring the behavioural determinants, including the barriers and enablers to pain management from the perspective of PwP, the role of healthcare professionals and impact of other symptoms alongside pain will inform the development of a fit for purpose, pain management toolkit for PwP.

Methods and analysis
A longitudinal qualitative study using semi structured interviews at two time points within an 18-month period will be conducted. PwP living with pain will be purposefully sampled from four NHS sites in the North of England. Data will be thematically analysed with reference to the Theoretical Domains Framework.

Ethics and dissemination
A favourable ethical opinion has been granted by the National Health Service East Midlands-Derby Research Ethics Committee (22/EM/0176) and the NHS Health Research Authority (IRAS ID 316403). Findings will be disseminated via scientific conferences, academic journals, lay summaries and public engagement events.

Leggi
Dicembre 2024

Comparison of preference-based health-related quality of life measures for chronic neck pain: a pooled analysis of data from three RCTs

Objectives
This study aimed to identify a preference-based health-related quality of life (HRQOL) measure that best reflects disease-specific features in patients with neck pain by comparing the characteristics of the instruments.

Design
Pooled data from three multicentre randomised controlled clinical trials (RCTs) on neck pain were included for analysis in this study.

Setting
All three RCTs were conducted between 2017 and 2020 in Korea, and patients were recruited from four hospitals and one university teaching hospital.

Participants
In total, 313 patients with neck pain were included in the three RCTs.

Primary and secondary outcome measures
A correlation analysis was conducted using Spearman’s correlation coefficients between preference-based HRQOL scores (EuroQol-5 Dimension 5 Levels (EQ-5D-5L) and Short-Form 6-Dimension version 1 (SF-6Dv1)) and the disease-specific measures for pain and function (Numerical Rating Scale (NRS), Visual Analogue Scale (VAS), Neck Disability Index (NDI) and Northwick Park Questionnaire).

Results
Spearman’s correlation analyses (p value 5), EQ-5D-5L appeared to better capture functional and pain aspects. Despite these differences, both instruments consistently reflected treatment-related improvements in pain and function. Distribution analysis further indicated that EQ-5D-5L and SF-6Dv1 were not fully interchangeable due to variations in domain-level scoring patterns and ceiling effects observed in EQ-5D-5L.

Conclusions
EQ-5D-5L showed stronger negative correlations with both pain and functional outcomes compared with SF-6Dv1, suggesting that it may better capture the functional aspects of chronic neck pain, particularly in moderate-to-severe conditions. However, the ceiling effect observed in EQ-5D-5L warrants caution when interpreting results in patients with mild neck pain. These findings provide practical guidance for selecting preference-based HRQOL measures in economic evaluations of musculoskeletal conditions, supporting more informed healthcare decision-making.

Trial registration number
NCT03294785, Post-results; NCT03558178, Results; NCT04035018, Post-results.

Leggi
Dicembre 2024

Efficacy of opioid combination versus single opioid for adult cancer pain: a protocol for systematic review and meta-analysis

Introduction
Chronic pain is one of the most common and serious symptoms of cancer. Despite the limitations of dose titration using only one type of opioid, the effects of opioid combinations are poorly understood.

Methods and analysis
This study will be conducted in accordance with the Cochrane Handbook of Systematic Reviews of Interventions 6.3. We will search the Cochrane Central Register of Controlled Trials (CENTRAL), Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Web of Science databases from their inception to June 2023. This review will consider all clinical trials involving patients aged ≥18 years who received opioids for chronic cancer pain. Two reviewers will independently screen and select relevant studies. The intervention will be a combination of opioids, including both strong and weak, to control cancer pain. The comparator will be set as a single opioid, with or without a placebo. For randomised controlled trials, version 2 of the Cochrane tool will be used to assess the risk of bias. For non-randomised studies, the risk of bias will be assessed using a tool for assessing the Risk of Bias In Non-randomised Studies of Interventions (ROBINS-I). The primary outcome will be pain response; if a quantitative synthesis is not appropriate, a synthesis without a meta-analysis will be undertaken. The quality of evidence for each primary outcome will be assessed using the Grading of Recommendations, Assessment, Development and Evaluation guidelines.

Ethics and dissemination
Ethical approval was not required for this systematic review and meta-analysis. The findings will be disseminated through peer-reviewed (open-access) journal publications and conference presentations. Given the widespread use of opioid-based cancer pain management in clinical practice, this study is expected to generate significant interest among physicians, many of whom are likely to review and consider the findings in the context of their clinical decision-making.

PROSPERO registration number
PROSPERO CRD42023427299.

Leggi
Dicembre 2024