Identifying outcomes and outcome measures in neonatal family-centered care trials: a systematic review.

BACKGROUND: A wide range of outcomes for infants and parents has been reported in clinical trials testing FCC interventions. This systematic review aimed to identify outcomes, outcome measures, and time-points reported in experimental studies testing FCC interventions in neonatal care units. METHODS: This review included experimental studies investigating FCC interventions in neonatal settings. Database searches were conducted in MEDLINE, EMBASE, CINAHL, Cochrane, PsycINFO, Scopus, JBI, Lilacs, and SciELO, completed in December 2022 and updated in November 2023. Critical appraisal was performed using the JBI checklist for randomized controlled trials, and a narrative synthesis process was used. Outcomes were categorized into the Comet Taxonomy core areas. RESULTS: The search identified 8787 papers; 42 studies were included in the analysis. Totally, 60 outcomes were identified: 42 infant and 18 parents' outcomes. Outcomes were clustered into 12 domains for infants and five domains for parents and measured by 97 outcome measures. The included studies reported 25 and 27 different time-points for infants and parents, respectively. CONCLUSION: This review of studies testing FCC interventions identified heterogeneity and inconsistency of outcomes, outcome measures, and time-points measuring the outcomes. Developing a core outcome set for FCC studies is warranted to benchmark the evidence and identify best-practices. IMPACT: This systematic review identified inconsistency of outcomes, outcome measures, and time-points reported in quantitative studies testing family-centered care interventions in neonatal care settings. The lack of standardized outcomes and outcome measures reported in clinical trials makes it difficult to synthesize data to provide conclusive recommendations. This systematic review will contribute to the development of a core outcome set for research testing family-centered care interventions in neonatal care settings.

Pain Medication Adherence in Patients with Cancer: A Pragmatic Review.

OBJECTIVE: Adherence to pain medication in patients with cancer is crucial for successful pain therapy. This review aimed to investigate the rate of adherence, which factors influence adherence, whether adherence differs in diverse patient populations, whether there are methods to improve adherence, and the relationship between adherence and pain relief. METHODS: This review was performed in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE/PubMed, Embase, Web of Science, Cochrane, and ClinicalTrials.gov were searched. All types of studies investigating adherence of patients with cancer, factors influencing adherence, and methods to improve adherence to pain medication were included. They were first screened on title and abstract and thereafter on full text. Selected articles were subjected to a quality assessment according to the PRISMA checklist. From included articles, study characteristics and outcomes were extracted. RESULTS: Of 795 articles, 18 were included. Different methods were used to measure adherence, which led to adherence rates ranging from 8.9% to 82.0%. White Americans and men were found to be more adherent than African Americans and women. Because of various barriers, adherence is often suboptimal. Fear of addiction, physiological and harmful effects, tolerance, and disease progression are common concerns. Interventions, such as pain education booklets, pain consults, and specialized nurses, may be beneficial to increase the adherence. Lower adherence rates were associated with lower pain relief. CONCLUSION: Adherence of cancer patients to pain medication is suboptimal. Health care workers should focus on addressing barriers to increase adherence to obtain better pain relief.

Effectiveness of Adjunctive Analgesics in Head and Neck Cancer Patients Receiving Curative (Chemo-) Radiotherapy: A Systematic Review.

OBJECTIVE: Our aim was to give an overview of the effectiveness of adjunctive analgesics in head and neck cancer (HNC) patients receiving (chemo-) radiotherapy. DESIGN: Systematic review. INTERVENTIONS: This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. PubMed, Embase, Web of Science, the Cochrane Library, and ClinicalTrials.gov were searched for studies concerning "head neck cancer," "adjunctive analgesics," "pain," and "radiotherapy." OUTCOME MEASURES: Pain outcome, adverse events, and toxicity and other reported outcomes, for example, mucositis, quality of life, depression, etc. RESULTS: Nine studies were included in our synthesis. Most studies were of low quality and had a high risk of bias on several domains of the Cochrane Collaboration tool. Only two studies comprised high-quality randomized controlled trials in which pregabalin and a doxepin rinse showed their effectiveness for the treatment of neuropathic pain and pain from oral mucositis, respectively, in HNC patients receiving (chemo-) radiotherapy. CONCLUSIONS: More high-quality trials are necessary to provide clear evidence on the effectiveness of adjunctive analgesics in the treatment of HNC (chemo-) radiation-induced pain.

Subjective, but not objective, cognitive complaints impact long-term quality of life in cancer patients.

OBJECTIVES: Cognitive complaints, of objective or subjective nature, may negatively impact cancer patients' quality of life (QoL). Further, the early detection of cognitive alterations may lead to an improved QoL. However, the content of such screening is yet unclear. This paper presents long-term QoL data of cancer patients treated with curative intent and its relation with objective and subjective cognitive complaints, and patient-reported outcome measures (PROMs). METHODS: QoL data, measured by the EORTC QLQ C-30, were obtained at baseline, 6 (T1), 12 (T2), and 24 months (T3) after treatment start, and compared between patients with and without objective and subjective cognitive complaints. The predictive value of PROMs was also examined. RESULTS: QoL data at baseline was collected in 125 patients. Response rates at T1, T2, and T3 were 84.7%, 81.5%, and 83.1%, respectively. Eighty-nine patients returned their QoL questionnaires at all times. Baseline subjective cognitive complaints had a stronger association with worse scores on patients' overall QoL and QoL subscale scores than objective cognitive complaints. An exploratory analysis into the value of PROMs in predicting long-term QoL at T3 revealed a significant effect for the Hospital Anxiety and Depression Scale-Depression and FACIT Fatigue scale. CONCLUSIONS: Self-perceived cognitive alterations are negatively associated with patients' overall QoL. As these troubles may already be present at baseline, oncology nurses should screen for the early signs of subjective cognitive complaints by use of PROMs, in order to refer the patient to proper intervention programs which may lead to an improved long-term QoL and faster reintegration into society.

Predictors of baseline cancer-related cognitive impairment in cancer patients scheduled for a curative treatment.

INTRODUCTION: Recent research in the field of cancer-related cognitive impairments (CRCI) has shown CRCI presentation prior to treatment initiation. Some have attributed these problems to worry and fatigue, whereas others have suggested an influence of age, IQ, and other psychosocial and medical factors. METHODS: Patients (≥18 years) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated with a baseline neuropsychological assessment including Patient-Reported Outcome Measures (PROMs). PROMs entailed distress, anxiety and depression, fatigue, and cognitive complaints. The neuropsychological assessment comprised several cognitive domains such as premorbid IQ, attention, processing speed, flexibility, verbal and visual episodic memory, and verbal fluency. RESULTS: Cross-sectional data of 125 patients were collected. Patients had a mean age of 60.9 years (range: 30.0-85.0) and comprised primarily females (65.6%). Patients presented with cancer of following sites: breast (44.0%), digestive (28.8%), urological (11.2%), gynecologic (8.0%), hematologic malignancy (4.8%), and lung (3.2%). Patients presented with a premorbid IQ of 105.3 (range: 79.0-124.0). In 29.6% of patients, a CRCI was detected. Binary logistic regression analyses showed that a lower premorbid IQ (ß = -.084, P < .01) and a higher level of fatigue (ß = -.054, P < .05) predicted baseline CRCI. Premorbid IQ also predicted performance on individual cognitive domains. Some domains were also influenced by age, gender, having a breast cancer diagnosis, and an active treatment for hypertension. CONCLUSION: Premorbid IQ and fatigue are important predictors of baseline CRCI. Therefore, we advise researchers to implement a short IQ test when conducting clinical trials on CRCI.

The distress thermometer predicts subjective, but not objective, cognitive complaints six months after treatment initiation in cancer patients.

OBJECTIVES: Research has indicated that cancer-related cognitive impairments (CRCI) may be influenced by psychosocial factors such as distress, worry and fatigue. Therefore, we aimed to validate the distress thermometer (DT) as a screening tool to detect CRCI six months post-treatment-initiation in a group of general cancer patients. METHODS: Patients (≥18 years, n = 125) with a histologically confirmed diagnosis of a solid cancer or hematological malignancy, scheduled for a curative treatment, were evaluated at baseline (T0) and six months post-treatment-initiation (T1) for CRCI by a neuropsychological assessment, including patient-reported outcome measures (PROMs). Assessed cognitive domains included premorbid intelligence, attention, processing speed, flexibility, verbal and visual episodic memory and verbal fluency. PROMs entailed distress (DT, cut-off ≥4, range 0-10), anxiety and depression, fatigue (FACIT-fatigue scale) and subjective cognitive complaints. RESULTS: At T0, 60.4% of patients showed a DT score of ≥4, whereas 50% met this criterion at T1. According to the definition of the International Cognition and Cancer Task Force, 25.5% and 28.3% of patients presented with a CRCI at T0 and T1, respectively. When evaluating the DT as a screening tool for CRCI at T1, data showed an inverse relationship between the DT and CRCI. ROC-curve analysis revealed an AUC <0.5. ROC-curve analyses evaluating the DT and FACIT-fatigue scale as screening tools for subjective cognitive complaints showed an AUC ± SE of, respectively, 0.642 ± 0.067 and 0.794 ± 0.057. CONCLUSIONS: The DT at T0 cannot be used to screen for objective CRCI at T1, but both the DT and FACIT-fatigue scale at T0 showed potential as screening tools for subjective cognitive complaints at T1.

Acetylcholinesterase inhibitors are associated with weight loss in older people with dementia: a systematic review and meta-analysis.

We conducted a systematic review and meta-analysis investigating the influence of acetylcholinesterase inhibitors (AChEIs) therapy on nutritional status and weight across observational and interventional studies. Two authors searched major electronic databases from inception until 10/14/2015 for longitudinal, open-label and randomised double-blind placebo controlled (randomised controlled trials (RCTs)) studies of AChEIs in patients with dementia reporting nutritional status outcome data. Out of 3551 initial hits, 25 studies (12 open-label trials, 9 RCTs and 4 longitudinal studies) including 10 792 patients with dementia were meta-analysed. In longitudinal studies (median follow-up 6 months), a significant cumulative incidence of weight loss between baseline and follow-up evaluation was observed (studies=2; 5%; 95% CI 1% to 34%, p<0.0001; I2=95%). These findings were confirmed in open-label trials (6%; 95% CI 4% to 7%, p<0.0001; I2=78%). In 9 RCTs (median follow-up 5 months), those taking AChEIs more frequently experienced weight loss than participants taking placebo (OR=2.18; 95% CI 1.50 to 3.17, p<0.0001; I2=29%). AChEIs therapy contributes to weight loss in patients with dementia, with a 2-fold increased risk observed in the meta-analysis of RCTs. Clinicians should carefully consider the benefit and risk of prescribing AChEIs. Nutritional status should be routinely evaluated in patients with dementia treated with AChEIs.

Stressors, Appraisal of Stressors, Experienced Stress and Cardiac Response: A Real-Time, Real-Life Investigation of Work Stress in Nurses.

BACKGROUND: Stress in health care professionals may reflect both the work and appraisal of work and impacts on the individuals, their patients, colleagues and managers. PURPOSE: The purpose of the present study is to examine physiological and psychological effects of stressors (tasks) and theory-based perceptions of work stressors within and between nurses in real time. METHODS: During two work shifts, 100 nurses rated experienced stress, affect, fatigue, theory-based measures of work stress and nursing tasks on electronic diaries every 90 min, whereas heart rate and activity were measured continuously. RESULTS: Heart rate was associated with both demand and effort. Experienced stress was related to demand, control, effort and reward. Effort and reward interacted as predicted (but only within people). Results were unchanged when allowance was made for work tasks. CONCLUSIONS: Real-time appraisals were more important than actual tasks in predicting both psychological and physiological correlates of stress. At times when effort was high, perceived reward reduced stress.

The experiences of physiotherapists delivering pain science education via an interpreter: a mixed-methods online survey.

OBJECTIVE: To explore physiotherapist's experiences of delivering Pain Science Education (PSE) via an interpreter to people with persistent pain. METHOD: A cross-sectional online survey study of UK Physiotherapists. The study protocol was registered on the Open Science Framework Registry. Seventy-seven physiotherapists with experience of delivering PSE via an interpreter completed the survey between January 16, 2023 and May 24, 2023. Feelings of stress and confidence the messages of PSE had been understood when delivering PSE with and without an interpreter were assessed on an 11-point Likert scale. In addition, drop-down, multi-selection lists were presented with barriers and facilitators to delivering PSE via an interpreter. Thematic analysis was undertaken of open text fields which allowed participants to elaborate on their responses. RESULTS: Physiotherapists were less confident the information had been understood -2.3 (-2.8 to -1.8) mean difference (95% Confidence Interval) and more stressed 2.3 (1.7 to 2.9) when delivering PSE via an interpreter compared to doing so without an interpreter (p < .001). From the open-text data, the overarching theme was Trust in the Interpretation with three sub-themes: 1) Family vs Professional Interpreter, 2) Therapist and Interpreter Relationship, and 3) Strong Preference for Face-Face Interpretation. CONCLUSIONS: UK Physiotherapists are less confident that patients understand the messages of PSE when delivered via an interpreter and they find it significantly more stressful than delivering PSE in English. Almost all participants encountered barriers to delivering PSE via an interpreter. Future research needs to explore the experience of patients and interpreters within this clinical context.

Harnessing the therapeutic effects of nature for chronic Pain: A role for immersive virtual reality? A narrative review.

BACKGROUND AND OBJECTIVE: There is a growing interest in the relationship between nature and pain relief. Evidence from environmental psychology, neuroscience and physiology-based studies point towards analgesic effects of nature being mediated through various cognitive, affective and/or autonomic factors. Being able to harness these therapeutic effects using immersive virtual reality (VR) could help to optimize and improve accessibility of nature-based environments as part of chronic pain management plans. In this narrative review, we present evidence supporting a new theoretical framework for nature-based analgesia and suggest ways for applying this through immersive VR. DATABASES AND DATA TREATMENT: We provide an overview of the evidence on (1) the therapeutic effects of nature on pain, (2) environmental psychology theory that underpins the health benefits of nature, (3) key mechanistic evidence from nature neuroimaging and physiology-based studies, (4) previous studies that have used VR-based nature in pain research and (5) how to design effective VR interventions that can be used to integrate nature into immersive 360 environments. RESULTS: We have demonstrated how environmental psychology, neuroscience and physiology-based research can be used to form a novel theoretical framework for nature-based analgesia. Using this framework, we identify how key aspects of nature can act as analgesic and how this can be harnessed using immersive VR. CONCLUSIONS: Through developing this theoretical framework, we have provided a foundation on which to guide future experimental and clinical studies as well as helping to improve the accessibility of nature for chronic pain patients through immersive VR technologies. SIGNIFICANCE: This review article summarizes key multidisciplinary evidence to help understand how nature exerts beneficial effects on pain processing. The use of this theoretical framework alongside advances in immersive VR technologies provides a springboard for future research and can be used to help develop new nature-based therapeutics using VR.

Therapy students' recommendations of physical activity for managing persistent low back pain in older adults.

Negative views of older adults can lead to suboptimal care. For older adults with persistent low back pain (LBP), promotion of physical activity by health care professionals is important. Health care professionals' views of older adults are influenced by their training. This study aimed to compare recommendations for physical activity for managing persistent LBP offered by students in physiotherapy and occupational therapy to an older person vs. a younger person. In a cross-sectional online survey, participants (N = 77) randomly received a vignette of either a 40-yr-old or 70-yr-old patient with persistent LBP. Other than age, the vignettes were identical. There was no difference between the younger and older vignettes in the likelihood of participants making overall appropriate physical activity recommendations--63% vs. 59%, OR (95% CI) = 1.19 (0.48-2.99), p = .71--although there was a trend toward age bias on recommendations specific to daily activity. Postqualification education may be where ageist views need to be addressed.

Managing chronic pain in older people.

This article presents the results of a collaborative project between the British Pain Society and British Geriatric Society to produce guidelines on the management of pain in older adults. The guidelines are the first of their kind in the UK and aim to provide best practice for the management of pain to all health professionals working with older adults in any care setting.

Practical Implementation of the Comprehensive Geriatric Assessment to Optimise Care for Older Adults with Cancer.

Whilst cancer remains a very serious health problem at any stage, cancer combined with increasing age creates an even more challenging situation for health care providers [...].

Developing the evidence and associated service models to support older adults living with frailty to manage their pain and to reduce its impact on their lives: protocol for a mixed-method, co-design study (The POPPY Study).

INTRODUCTION: The Pain in Older People with Frailty Study is a mixed-method, co-design study, which aims to develop the content, implementation strategies, service and professional guidance to support older adults with frailty to manage their pain. METHODS AND ANALYSIS: The study has four phases: Phase 1, research evidence and information synthesis from randomised controlled trials of multicomponent pain management programmes and psychological therapies for community-dwelling older adults. Phase 2, qualitative interviews with 30 community-dwelling older adults (≥75 years) living with frailty and persistent pain, including dyadic interviews with a spouse or unpaid carer. Phase 3, qualitative interviews with healthcare professionals (HCPs) working within various pain service types; 5-8 HCPs per service and up to 12 services including primary care, secondary care, tertiary centres and services with voluntary sector input. Phase 4, co-design workshops with older adults, HCPs and commissioners. Inclusion criteria (Phase 2): community-dwelling older adults (≥75 years) living with frailty and persistent pain. Exclusion criteria (Phase 2): care home residents, a dementia or cancer diagnosis. Cancer survivors, ≥5 years cancer free, and not undergoing active cancer treatment can participate. Analysis for Phase 1 will use narrative synthesis, Phase 2 will use grounded theory analysis and Phase 3 will use thematic analysis. Oversight is provided from a patient and public involvement group and an independent steering committee. ETHICS AND DISSEMINATION: The protocol was approved by Leeds-East Research Ethics Committee on 28 April 2022 (22/YH/0080). Consent is sought if an individual is willing to participate (Phases 2-4) and has capacity. Findings will be disseminated at conferences, in newsletters and journals and to local authorities and charities.

Diagnostic Performance of Screening Tools for Depressive Symptoms in Vulnerable Older Patients with Cancer Undergoing Comprehensive Geriatric Assessment (CGA): Results from the SCREEN Pilot Study.

Depression is a common and disabling disorder in later life, particularly among people with poor physical health. There are many screening tools available that can be used to examine depressive symptoms; however, not all of them may be appropriate or accurate for older adults with cancer. This pilot study was designed to test the diagnostic performance of two screening tools and their short versions in a cohort of vulnerable (G8 score ≤ 14/17) older patients with cancer undergoing comprehensive geriatric assessment (CGA). The prospective analysis covered 50 vulnerable patients with cancer aged ≥70 years. The diagnostic performance of the Geriatric Depression Scale (GDS)-15, GDS-4, Patient Health Questionnaire (PHQ)-9 and PHQ-2 was compared to the 'gold standard' Structured Clinical Interview for DSM-5 Disorders (SCID-5-S) depression module A. The sensitivity and specificity in detecting depressive symptoms were the highest in the case of PHQ-2, with an area under the receiver operating characteristic curve (AUROC) of 92.7%. The AUROC for the 9-item version, PHQ-9, was 90.2%. For the GDS-15 and GDS-4, the AUROC was only 56.2% and 62.0%, respectively. The SCREEN pilot study illustrates the potential benefit of using a shorter screening tool, PHQ-2, to identify older patients with cancer who would benefit from a more in-depth emotional evaluation as part of a CGA.

"I feel so stupid because I can't give a proper answer " How older adults describe chronic pain: a qualitative study.

BACKGROUND: Over 50% of older adults experience chronic pain. Poorly managed pain threatens independent functioning, limits social activities and detrimentally affects emotional wellbeing. Yet, chronic pain is not fully understood from older adults' perspectives; subsequently, pain management in later life is not necessarily based on their priorities or needs. This paper reports a qualitative exploration of older adults' accounts of living with chronic pain, focusing on how they describe pain, with a view to informing approaches to its assessment. METHODS: Cognitively intact men and women aged over sixty-five who lived in the community opted into the study through responding to advertisements in the media and via contacts with groups and organisations in North-East Scotland. Interviews were transcribed and thematically analysed using a framework approach. RESULTS: Qualitative individual interviews and one group interview were undertaken with 23 older adults. Following analysis, the following main themes emerged: diversity in conceptualising pain using a simple numerical score; personalising the meaning of pain by way of stories, similes and metaphors; and, contextualising pain in relation to its impact on activities. CONCLUSIONS: The importance of attending to individuals' stories as a meaningful way of describing pain for older adults is highlighted, suggesting that a narrative approach, as recommended and researched in other areas of medicine, may usefully be applied in pain assessment for older adults. Along with the judicious use of numerical tools, this requires innovative methods to elicit verbal accounts, such as using similes and metaphors to help older adults describe and discuss their experience, and contextualising the effects of pain on activities that are important to them.

Psychosocial Care after Cancer Diagnosis: Recent Advances and Challenges.

Psychosocial oncology is coming of age [...].

Evidence-based clinical practice guidelines on the management of pain in older people - a summary report.

OBJECTIVE: The objective of this study is to develop an update of the evidence-based guidelines for the management of pain in older people. DESIGN: Review of evidence since 2010 using a systematic and consensus approach is performed. RESULTS: Recognition of the type of pain and routine assessment of pain should inform the use of specific environmental, behavioural and pharmacological interventions. Individualised care plans and analgesic protocols for specific clinical situations, patients and health care settings can be developed from these guidelines. CONCLUSION: Management of pain must be considered as an important component of the health care provided to all people, regardless of their chronological age or severity of illness. By clearly outlining areas where evidence is not available, these guidelines may also stimulate further research. To use the recommended therapeutic approaches, clinicians must be familiar with adverse effects of treatment and the potential for drug interactions.

Smartphone Applications Designed to Improve Older People's Chronic Pain Management: An Integrated Systematic Review.

(1) Background: Older people's chronic pain is often not well managed because of fears of side-effects and under-reporting. Telehealth interventions, in the form of smartphone applications, are attracting much interest in the management of chronic diseases, with new and evolving approaches in response to current population demographics. However, the extent to which telehealth interventions may be used to promote and effect the self-management of chronic pain is not established. (2) Aim: To provide an objective review of the existing quantitative and qualitative evidence pertaining to the benefits of smartphone applications for the management of chronic pain in older people. (3) Methods: A literature search was undertaken using PubMed, Medline, CINAHL, Embase, PsychINFO, the Cochrane database, Science Direct and references of retrieved articles. The data were independently extracted by two reviewers from the original reports. (4) Results: This integrative systematic review identified 10 articles considering smartphone applications related to self-management of chronic pain among older adults. (5) Conclusions: It is important for future research to not only examine the effects of smartphone initiatives, but also to compare their safety, acceptability, efficacy and cost-benefit ratio in relation to existing treatment modalities.