Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain

BACKGROUND: The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions. METHODS: We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100 mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses. RESULTS: We included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I(2) = 93%, relative MCID: I(2) = 75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40 mm (standardised to a 100 mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values. CONCLUSIONS: The MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial

Effectiveness of community-based football compared to usual care in men with prostate cancer:Protocol for a randomised, controlled, parallel group, multicenter superiority trial (The FC Prostate Community Trial)

BACKGROUND: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer. METHODS: Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy–Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period. DISCUSSION: Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT0243079

Community-based football in men with prostate cancer:1-year follow-up on a pragmatic, multicentre randomised controlled trial

BACKGROUND:Physical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted. METHODS AND FINDINGS:We conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI -1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI -0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (-0.9 kg [95% CI -1.7 to -0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report. CONCLUSIONS:In this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football proved to be acceptable, even when club membership was not subsidised. TRIAL REGISTRATION:ClinicalTrials.gov NCT02430792

Easier in Practice Than in Theory:Experiences of Coaches in Charge of Community-Based Soccer Training for Men with Prostate cancer—A Descriptive Qualitative Study

BACKGROUND: Evidence suggests that community-based exercise programs and sports participation benefit long-term physical activity adherence and promote health in clinical populations. Recent research shows that community-based soccer can improve mental health and bone health and result in fewer hospital admissions in men with prostate cancer. However, little knowledge exists on what coaches experience, leading to a scarcity of knowledge on how to assist them in promoting and supporting the sustainability of programs. The purpose of this study was to explore the experiences of non-professional soccer coaches in providing community-based soccer training for men with prostate cancer. RESULTS: We interviewed 13 out of 21 eligible non-professional soccer coaches in charge of delivering the Football Club Prostate Community program, which is community-based soccer training for men with prostate cancer at 12 local soccer clubs across Denmark. Qualitative content analysis, as described by Graneheim and Lundman, was applied to analyze the data using NVivo 12 software. We identified the five following overall categories with 10 subcategories on what the coaches experienced: (1) enabling training of a clinical population in a community setting, (2) dedication based on commitment, (3) coaching on the players’ terms, (4) navigating the illness, and (5) ensuring sustainability. Collectively, the findings suggest that, while the coaches felt adequately prepared to coach, their coaching role developed and was refined only through interaction with the players, indicating that coaching clinical populations may be easier in practice than in theory and a potentially transformative learning experience. CONCLUSIONS: Non-professional soccer coaches in charge of delivering soccer training for men with prostate cancer value being educated about specific illness-related issues. Initial concerns about how to coach a clinical population disappeared once the coaches engaged with the players and developed their own team norms and illness management strategies. They also gained a broader perspective on their own lives, which they valued and would not otherwise have achieved by coaching a healthy population. Our study indicates that sustainable implementation and the program’s sustainability can be promoted and supported through additional formal, easily accessible communication with trained health professionals and by networking with peer coaches. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s40798-022-00424-z

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis

Men diagnosed and treated for prostate cancer experience severe adverse effects on quality of life (QoL) and metabolic health, some of which may be preventable or reversible with exercise, the benefits of which healthcare providers and patients increasingly acknowledge, though existing evidence on its effects varies in significance and magnitude. We aimed to review the effect of exercise on QoL and metabolic health in a broad prostate cancer population. A systematic search was conducted in nine databases and eligible trials were included in the meta-analytic procedure. All outcomes were stratified into aerobic exercise, resistance exercise, and a combination of both. The review identified 33 randomised controlled trials (2567 participants) eligible for inclusion. Exercise had a borderline small positive effect on cancer-specific QoL (standardised mean difference (SMD) = 0.10, 95% confidence interval (CI) −0.01–0.22), and a moderate to large effect on cardiovascular fitness (SMD = 0.46, 95% CI 0.34–0.59) with aerobic exercise being the superior modality (SMD = 0.60, 95% CI 0.29–0.90). A positive significant effect was seen in lower body strength, whole-body fat mass, general mental health, and blood pressure. No significant effect was seen in fatigue, lean body mass, and general physical health. We thereby conclude that exercise is effective in improving metabolic health in men diagnosed with prostate cancer, with aerobic exercise as the superior modality. The effect of exercise on QoL was small and not mediated by choice of exercise modality

Development of an Educational Program for Non-Professional Soccer Coaches in Charge of Community-Based Soccer in Men with Prostate Cancer: a Qualitative Study

Abstract Background While clinical trials have demonstrated the benefits of structured exercise for prostate cancer survivors, few attempts have been made to investigate and implement sustainable community-based exercise programs supporting adoption of long-term physical activity behavior. Against this background, the aims of this study was to explore the perspectives of experts and stakeholders on the development of a training course and intervention manual used to support the delivery of community-based soccer training in men with prostate cancer (the FC Prostate Community [FCPC] trial). Methods A two-step qualitative design including triangulation of methods, data sources, and researchers. Step 1 comprised key informant interviews with clinical and scientific experts (n = 4). Step 2 included stakeholder focus group interviews with nurses (n = 5), non-professional soccer coaches and club representatives (n = 5), and prostate cancer survivors (n = 7). Results Four themes emerged from the analysis of the key informant interviews: The Coach’s Qualifications, Structure of the Training, Prevention of Injuries, and A Non-Patient Environment, which informed development of the training course and intervention manual. The stakeholders added the importance of clarifying the Responsibility of the Coach, the value of Positive Competition, and Social Inclusion of the prostate cancer survivors in the club. Based on these results, we present the final templates for the training course and intervention manual. Conclusions No general set of rules or safety measures to promote or optimize the delivery of community-based exercise in cancer survivors is recommended. However, the general principles related to the necessary clarification of the coach’s responsibility in relation to the prevention and management of injuries and participant adherence through a non-patient environment may be transferable to the training and education of other groups of lay persons in charge of delivering exercise interventions to other clinical subpopulations in a non-hospital setting