Study protocol for Attachment & Child Health (ATTACHTM) program: promoting vulnerable Children's health at scale.

BACKGROUND: Children's exposure to toxic stress (e.g., parental depression, violence, poverty) predicts developmental and physical health problems resulting in health care system burden. Supporting parents to develop parenting skills can buffer the effects of toxic stress, leading to healthier outcomes for those children. Parenting interventions that focus on promoting parental reflective function (RF), i.e., parents' capacity for insight into their child's and their own thoughts, feelings, and mental states, may understand help reduce societal health inequities stemming from childhood stress exposures. The Attachment and Child Health (ATTACHTM) program has been implemented and tested in seven rapid-cycling pilot studies (n = 64) and found to significantly improve parents' RF in the domains of attachment, parenting quality, immune function, and children's cognitive and motor development. The purpose of the study is to conduct an effectiveness-implementation hybrid (EIH) Type II study of ATTACHTM to assess its impacts in naturalistic, real-world settings delivered by community agencies rather than researchers under more controlled conditions. METHODS: The study is comprised of a quantitative pre/post-test quasi-experimental evaluation of the ATTACHTM program, and a qualitative examination of implementation feasibility using thematic analysis via Normalization Process Theory (NPT). We will work with 100 families and their children (birth to 36-months-old). Study outcomes include: the Parent Child Interaction Teaching Scale to assess parent-child interaction; the Parental Reflective Function and Reflective Function Questionnaires to assess RF; and the Ages and Stages Questionnaire - 3rd edition to examine child development, all administered pre-, post-, and 3-month-delayed post-assessment. Blood samples will be collected pre- and post- assessment to assess immune biomarkers. Further, we will conduct one-on-one interviews with study participants, health and social service providers, and administrators (total n = 60) from each collaborating agency, using NPT to explore perceptions and experiences of intervention uptake, the fidelity assessment tool and e-learning training as well as the benefits, barriers, and challenges to ATTACHTM implementation. DISCUSSION: The proposed study will assess effectiveness and implementation to help understand the delivery of ATTACHTM in community agencies. TRIAL REGISTRATION: Name of registry: https://clinicaltrials.gov/. REGISTRATION NUMBER: NCT04853888 . Date of registration: April 22, 2021.

False-Positive Results and Incidental Findings with Annual CT or PET/CT Surveillance in Asymptomatic Patients with Resected Stage III Melanoma.

OBJECTIVE: The aim of this study was to quantify false-positive and incidental findings from annual surveillance imaging in asymptomatic, American Joint Committee on Cancer stage III melanoma patients. METHODS: This was a cohort study of patients treated at Melanoma Institute Australia (2000-2015) with baseline computed tomography (CT) or positron emission tomography (PET)/CT imaging and at least two annual surveillance scans. False-positives were defined as findings suspicious for melanoma recurrence that were not melanoma, confirmed by histopathology, subsequent imaging, or clinical follow-up, while incidental findings were defined as non-melanoma-related findings requiring further action. Outcomes of incidental findings were classified as 'benign' if they resolved spontaneously or were not seriously harmful; 'malignant' if a second malignancy was identified; or 'other' if potentially harmful. RESULTS: Among 154 patients, 1022 scans were performed (154 baseline staging, 868 surveillance) during a median follow-up of 85 months (interquartile range 56-112); 57 patients (37%) developed a recurrence. For baseline and surveillance imaging, 124 false-positive results and incidental findings were identified in 81 patients (53%). The frequency of these findings was 5-14% per year, and an additional 181 tests, procedures, and referrals were initiated to investigate these findings. The diagnosis was benign in 109 findings of 124 findings (88%). Fifteen patients with a benign finding underwent an unnecessary invasive procedure. Surveillance imaging identified distant metastases in 20 patients (13%). CONCLUSION: False-positive results and incidental findings occur in at least half of all patients undergoing annual surveillance imaging, and the additional healthcare use is substantial. These findings persist over time. Clinicians need to be aware of these risks and discuss them with patients, alongside the expected benefits of surveillance imaging.

Long-bone fracture pain management in the emergency department.

INTRODUCTION: The purposes of this study were to investigate the adequacy of pain management for patients with long-bone fractures seen in the emergency department and to determine whether racial disparities exist. METHODS: The design was an exploratory, correlational design using patient data abstract ed from electronic medical records of 2 major urban medical centers located in the Southeastern United States. Data collected included demographics, time of initial pain assessment by the registered nurse, time of pain medication administration, severity of pain, fracture location by radiograph, type of pain medication, and route-dosage of pain medication administered. The primary outcome variable, which was the pain management index, was calculated and used as a measure of adequate pain management. RESULTS: The majority of the sample (N = 218) was female (61%) and white (63%), with 28% black and about 10% of the sample consisting of other minorities. Seventy-nine (36%) of the 218 patients received no medication while in the emergency department despite a mean pain score of 6.9 (SD = 2.5) on a 0 to 10 scale representing moderate to severe pain. Patients who received pain medication (n = 126) waited for the medication 1.76 hours (±1.47). Among the patients who received an analgesic (n = 126), younger patients, black patients, and those with higher pain severity were more likely to receive inadequate pain management than were white patients. DISCUSSION: According to the pain management index, the majority of the patients in this study received inadequate pain management while in the emergency department. Future interventions may need to focus on giving ED nurses information about inadequate pain management and disparities in pain management in the ED setting and exploring possible reasons for disparities in order to ultimately improve patient care.

Racial and ethnic disparities in cancer pain management.

This study explored the ways in which racially and ethnically diverse patients differ in their perceptions of the cancer pain experience, barriers to treatment, and satisfaction with treatment. This cross-sectional descriptive study was conducted at four cancer treatment centers and one cancer clinic in the southeastern United States and included 66 White, African-American, Latino, and American Indian cancer patients experiencing pain related to disease or disease progression. Pain Management Index (PMI) scores were calculated and subjects provided responses to the Cancer Pain Experience questionnaire, the Barriers Questionnaire, and a modified American Pain Society Satisfaction Survey. African-Americans reported a low PMI score. Whites reported the lowest mean level of agreement with all statements about barriers to pain relief. Addressing differences in patient beliefs about what constitutes successful pain treatment and treatment satisfaction, caregiver behaviors, and system characteristics might improve the quality of care and possibly reduce the mortality of cancer patients with pain.

Quality of life patient-reported outcomes for locally advanced cutaneous melanoma.

Locally advanced cutaneous melanoma has marked quality-of-life implications; however, the patient experience of symptom management and subsequent impact on quality of life has not been well described. This study aims to address the impact on patients of advanced cutaneous melanoma through qualitative interviews. Adults with stage IIIB, IIIC, or IV (M1a) cutaneous melanoma were recruited from two cancer centers in the USA and one in Australia. Telephone interviews were conducted to assess how locoregionally advanced cutaneous melanoma impacted everyday life. Interviews were recorded, transcribed, and coded for qualitative analysis. Twenty-two melanoma patients were interviewed, mean age 69.7 years (range: 52-83), 64% male. The study included stage IIIB (36%), stage IIIC (59%), and stage IV M1a (5%) patients. Emotional health/self-perception issues were the most commonly identified (41% of patient impact expressions), including worry, concern, embarrassment, self-consciousness, fear, and thoughts of death. Limitations of lifestyle and activities were also identified (28% of expressions) including leisure and social activities, physical functioning, general functioning, and personal care. Coping strategies such as modified clothing choices, increased use of pain and/or anti-inflammatory medications, and avoidance/protection from the sun represented 20% of all impact expressions. Ratings of the degree of difficulty patients experienced (using an 11-point numerical rating scale) ranged from 0.0 to 10.0 (mean 5.7, SD 2.9). Condition-related and treatment-related factors were well characterized in patients with locally advanced cutaneous melanoma. This provides a strong foundation for assessment of how cutaneous melanoma impacts quality of life.

Adherence to intravenous chemotherapy in African American and white women with early-stage breast cancer.

BACKGROUND: Adherence to intravenous chemotherapy offers survival and recurrence-free benefits for women diagnosed with early-stage breast cancer. However, previous studies have found that African American women are more likely to discontinue intravenous chemotherapy early, thus shortening their survival. Yet the existence of racial differences and predictors of adherence to chemotherapy treatment between African American and white women are largely understudied or inconsistent. OBJECTIVE: The purposes of this study were to examine factors that influence the decision to adhere to chemotherapy in African American and white women diagnosed with early-stage breast cancer and to test for racial differences that may exist in this sample. INTERVENTIONS/METHODS: The study recruited a convenience sample of 99 African American and white women. Factors examined were sociodemographic variables (age, race, access to healthcare), social support, religious coping, chemotherapy adverse effects, depression, breast cancer knowledge, health beliefs, cancer fatalism, and days from diagnosis to treatment. Data analyses included logistic regression modeling. RESULTS: No racial differences in adherence to intravenous chemotherapy between African American and white women were found (χ = 2.627, P = .10). Days to treatment (odds ratio [OR], 0.982, P = .058), health insurance (OR, 0.121; P = .016), change in depression (OR, 0.935; P = .118), and symptom severity (OR, 0.950; P = .038) were independently associated with nonadherence to chemotherapy. CONCLUSIONS: This study provides emerging evidence of factors that may be potentially modified with interventions at the clinical setting. IMPLICATIONS FOR PRACTICE: The findings can be used to spearhead future intervention studies that improve treatment decision making to chemotherapy adherence.

Pain Intensity and Pain Interference in Patients With Lung Cancer: A Pilot Study of Biopsychosocial Predictors.

OBJECTIVE: To explore biopsychosocial factors (beliefs, depression, catastrophizing cytokines) in individuals newly diagnosed with lung cancer and no pain to determine their relationship at diagnosis and across time and to determine whether these factors contribute to pain intensity or pain interference with function at pain onset. MATERIALS AND METHODS: A longitudinal, exploratory, pilot study was implemented in a private medical center and a VA medical center in the southeast. Twelve subjects not experiencing pain related to cancer of the lung or its treatment were recruited. A Karnofsky status of 40% and hemoglobin of 8 g were required. Five questionnaires were completed and 10 mL of blood was drawn at baseline; 4 questionnaires and blood draws were repeated monthly for 5 months. One baseline questionnaire and a pain assessment were added at final. Demographic, clinical, and questionnaire data were summarized; standardized scale scores were calculated. RESULTS: Biopsychosocial scores that were low at baseline increased from T1-T4 but decreased slightly T5-T6. Individuals with higher pain intensity and higher pain interference at final had higher psychosocial scores at baseline than individuals with lower pain intensity and lower pain interference at final. CONCLUSIONS: Unrelated to disease stage, metastasis, or treatment, unique levels of biopsychosocial factors are observed in patients newly diagnosed with lung cancer who report higher levels of pain intensity and higher levels of pain interference at the time pain occurs. Replication studies are needed to validate this response pattern and determine the value of repeated individual assessments.

Biobehavioral factors in cancer pain.

Despite the presence of pathology in cancer pain, the pain experience in adult cancer patients cannot be totally explained by the extent of such pathology. Unlike chronic benign pain very little research on the role of biobehavioral factors has been conducted to help explain this paradox. The literature on the role of biobehavioral factors in the cancer pain experience is reviewed. A brief review of epidemiology and pathophysiology is presented. Following this, the biobehavioral literature was organized according to research on psychological characteristics and environmental factors. Research addressing affective, cognitive, behavioral and physiological reactions to pain was also discussed. Despite the paucity of studies, the review suggested the following: (1) personality factors do not appear to play a consistent role in the modulation of pain in cancer patients; (2) the work on environmental influences on cancer pain indicate a weak association between such factors as social network and pain intensity; (3) studies on affective state indicate minimal relationships to pain, and lastly, (4) studies on cognitive responses to pain in cancer patients and their influence on the pain experience have not been conducted. To date, in the areas where biobehavioral factors have been investigated, the findings appear modest. However, many potential variables, e.g., self-esteem, the role of family, the role of models, past or current work environments, social learning factors and responses to pain such as fear, somatization and reattribution have not been explored with cancer patients. While the influence of biobehavioral factors in adult cancer pain appear to be relatively modest, the literature is not extensive. Increased efforts at more precisely determining the input of such factors in cancer pain are warranted, particularly given the role of such variables in other recurrent and chronic pain states.

Biobehavioral pain profile: development and psychometric properties.

Although a number of self-report indices that measure intensity and psychosocial components of the pain experience are available, these measures do not assess the range of cognitive, behavioral, and physiological reactions frequently associated with pain. This paper describes the initial determination of the psychometric properties of the Biobehavioral Pain Profile (BPP) developed to measure these reactions. The BPP is a 41-item self-report scale tested in a sample of 617 subjects with chronic recurrent pain, chronic non-malignant pain or chronic malignant pain. Kaiser's measure of sampling adequacy was 0.918. Factor analysis revealed 6 theoretically meaningful factors: Environmental Influences, Loss of Control, Health Care Avoidance, Past and Current Experience, Physiological Responsivity, and Thoughts of Disease Progression. Cronbach's alpha scores for the specific subscales ranged from r = 0.77 to r = 0.94. Test-retest reliability for the scales ranged from 0.57 to 0.73. Low correlations among the BPP and general indices of fear, depression, anxiety, body consciousness and social desirability are reported. The BPP appears to provide a unique composite assessment of self-report of behavioral, physiological, and cognitive reactions to pain experienced by individuals with a wide range of pain problems.

Is patient satisfaction a legitimate outcome of pain management?

Though many studies have measured patient satisfaction with pain management using the American Pain Society (APS) Satisfaction Survey or its variants, little is known about the relationship among the survey items, or whether items relate to satisfaction at all. In an effort to refine the measurement of patient satisfaction, a modified version of the APS survey, which was given to 787 patients as part of a study of postoperative pain management in six community hospitals, was subjected to principal components analysis to determine the survey's empirical structure. Correlations among the five components found were low; a weak relationship (r = -0.24) was discovered between pain intensity and satisfaction. A heuristic model estimated by structural equations analysis yielded additional insights. Though many items thought to influence patient satisfaction were not closely related to patient-reported satisfaction, they indicate important clinical factors relevant to quality of care, and thus, to continuing quality improvement (CQI) efforts. Results suggest that satisfaction was influenced by effectiveness of medication, independent of pain intensity, and by communication. Pain severity ratings near the time satisfaction was measured were more influential than earlier ratings.

Development and testing of the pain opioid analgesics beliefs scale in Taiwanese cancer patients.

The purpose of the study was to develop and preliminarily test the feasibility, validity, reliability, and factor structures of the Pain Opioid Analgesics Beliefs Scale-Cancer (POABS-CA) in hospitalized adults diagnosed with cancer in Taiwan. This scale was developed in three phases. In Phase I, item development was based on qualitative analysis as well as a review of the literature. Face validity, content validity, and feasibility were also evaluated. In Phase II, internal consistency reliability was further tested in 42 subjects with pain. In Phase III, test-retest reliability, internal consistency, and essential construct validity were further assessed in a sample of 361 hospitalized cancer patients with pain. The POABS-CA evolved from testing as a 10-item 5-point Likert-type instrument. Higher scores indicated more negative beliefs regarding opioids and their use in managing pain. Satisfactory face validity and content validity were found. The POABS-CA was also shown to be a reliable and stable pain belief scale, with Cronbach's alpha and test-retest reliability of 0.70 and 0.94, respectively. Two factors, namely pain endurance beliefs and negative effect beliefs, were extracted from the principal component factor analysis to support the construct validity. In conclusion, preliminary evidence indicates the POABS-CA is a reliable, stable, valid and easily applied scale for assessing beliefs regarding opioid use for cancer pain. Further studies should test this scale in different populations to increase its applications in cancer pain management.

Using reflexology for pain management. A review.

More than two thirds of Americans with chronic pain are now using complementary and alternative therapies. One complementary and alternative therapy, reflexology, has a long history and has been found useful on a case-by-case basis. This article provides a review of the literature on the use of reflexology as a therapy in pain management. Although reflexology is widely used, systematic research is needed to examine its effectiveness. To date, however, only a few studies have focused on reflexology's use in pain management. Because reflexology is a noninvasive, nonpharmacological therapy, nurses are in a position to do research on and make decisions about its clinical effectiveness.

Cognitive-behavioral therapy: tailored to the individual.

Cognitive-behavioral therapy focuses on the cognitive, affective, and behavioral components of the pain experience. Cognitive-behavioral strategies can be used to treat chronic pain and chronic intermittent pain. The strategies concentrate on emotional, behavioral, and social responses, helping patients to increase their feelings of control or feelings of self efficacy regarding control.

The effect of foot reflexology on pain in patients with metastatic cancer.

Thirty-six oncology inpatients participated in this third pilot study investigating the effects of foot reflexology in which equianalgesic dosing was calculated. Foot reflexology was found to have a positive immediate effect for patients with metastatic cancer who report pain, although there was no statistically significant effect at 3 hours after intervention or at 24 hours after intervention. Further study is suggested for foot reflexology delivered by family in the homes for management of cancer pain.

Tailoring cognitive-behavioral treatment for cancer pain.

Though it has been shown that cancer patients report cognitive, behavioral, and physiologic responses to pain, little attention has been paid to the benefits of cognitive-behavioral therapy (CBT) protocols tailored to patient characteristics. To determine whether a profile-tailored CBT treatment program was more effective than either standard CBT or usual care in changing outcomes for patients with cancer-related pain, 131 patients receiving treatment at four sites were randomly assigned to standard CBT, profile-tailored CBT, or usual care. CBT patients attended five 50-minute treatment sessions. When compared to standard CBT patients, profile-tailored CBT patients experienced substantial improvement from baseline to immediately post-intervention in worst pain, least pain, less interference of pain with sleep, and less confusion. From baseline to one-month post-intervention, profile-tailored patients saw greater improvement in less interference of pain with activities, walking, relationships, and sleep; less composite pain interference; and less mobility and confusion symptom distress. Standard CBT and usual care patients experienced little change. Compared to profile-tailored CBT patients, standard CBT patients showed greater improvement at six-months post-intervention with less average pain, less pain now, better bowel patterns, lower summary symptom distress, better mental quality of life, and greater improvement in Karnofsky performance status; usual care patients showed little change. More research is needed to refine the matching of cognitive-behavioral treatments to psychophysiologic patient profiles, and to determine a treatment period that does not burden those patients too fatigued to participate in a five-week program. Delivery of CBT by home visits, phone, or Internet needs to be explored further.