A PET [18F]altanserin study of 5-HT2A receptor binding in the human brain and responses to painful heat stimulation

There is a large body of evidence that serotonin [5-hydroxytryptamine (5-HT)] plays an important role in the transmission and regulation of pain. Here we used positron emission tomography (PET) to study the relationship between baseline 5-HT_2A binding in the brain and responses to noxious heat stimulation in a group of young healthy volunteers. Twenty-one healthy subjects underwent PET scanning with the 5-HT_2A antagonist, [¹⁸F]altanserin. In addition, participants underwent a battery of pain tests using noxious heat stimulation to assess pain threshold, pain tolerance and response to short-lasting phasic and long-lasting (7-minute) tonic painful stimulation. Significant positive correlations were found between tonic pain ratings and [¹⁸F]altanserin binding in orbitofrontal (r = 0.66; p = 0.005), medial inferior frontal (r = 0.60; p = 0.014), primary sensory–motor (r = 0.61; p = 0.012) and posterior cingulate (r = 0.63; p = 0.009) cortices. In contrast, measures of regional [¹⁸F]altanserin binding did not correlate with pain threshold, pain tolerance, or suprathreshold phasic pain responses. These data suggest that cortical 5-HT_2A receptor availability co-varies with responses to tonic pain. The correlation between [¹⁸F]altanserin binding in prefrontal cortex and tonic pain suggests a possible role of this brain region in the modulation and/or cognitive-evaluative appreciation of pain.     

Pain Catastrophizing and Pain-Related Fear in Osteoarthritis Patients: Relationships to Pain and Disability

This study examined the degree to which pain catastrophizing and pain-related fear explain pain, psychological disability, physical disability, and walking speed in patients with osteoarthritis (OA) of the knee. Participants in this study were 106 individuals diagnosed as having OA of at least one knee, who reported knee pain persisting for six months or longer. Results suggest that pain catastrophizing explained a significant proportion (all Ps ≤ 0.05) of variance in measures of pain (partial r² [pr²] = 0.10), psychological disability (pr² = 0.20), physical disability (pr² = 0.11), and gait velocity at normal (pr² = 0.04), fast (pr² = 0.04), and intermediate speeds (pr² = 0.04). Pain-related fear explained a significant proportion of the variance in measures of psychological disability (pr² = 0.07) and walking at a fast speed (pr² = 0.05). Pain cognitions, particularly pain catastrophizing, appear to be important variables in understanding pain, disability, and walking at normal, fast, and intermediate speeds in knee OA patients. Clinicians interested in understanding variations in pain and disability in this population may benefit by expanding the focus of their inquiries beyond traditional medical and demographic variables to include an assessment of pain catastrophizing and pain-related fear.     

Hopelessness in Turkish cancer inpatients: The relation of hopelessness with psychological and disease-related outcomes

The purpose of this study was to investigate the hopelessness level and the relationship of depression, anxiety and disease-related factors to the presence of hopelessness among Turkish patients with cancer. Ninety-five patients hospitalized for cancer treatments were recruited for current study. Data were collected by using a demographic questionnaire, the Pain Numeric Rating Scale, the Beck Hopelessness Scale, and the Hospital Anxiety Depression Scale. The mean hopelessness score was 5.20 ± 4.39. There were significant differences in terms of hopelessness between the patients who had metastasis and pain as compared with those without metastasis and pain (p < 0.05). There were also found that significant correlation between hopelessness and depression and between hopelessness and anxiety (r = 0.721; r = 0.645, respectively, p < 0.001). Foreword stepwise multiple regression analysis revealed that the independent predictors of hopelessness were depression score and thr presence of metastasis (F = 55.133; p < 0.001). The findings suggest that levels of hopelessness among cancer patients with pain and metastasis are higher than among those without pain and metastasis, and that the severity of pain, anxiety, and depression is positively correlated with hopelessness level. The assessment of hopelessness, pain, anxiety and depression levels of the patients with cancer should be an essential part of health care practice. Therefore, when arranging care assessment, to evaluate hopelessness could help professionals to appropriately refer patients to further psychological care resources.     

Psychometric comparison of single-item,short, and comprehensive depression screening measures in Korean young adults

BackgroundIntegrating long depression-screening instruments into routine clinical practice and research studies is often impractical, necessitating short-item if not single-item measures with comparable psychometric properties.ObjectiveTo examine whether single-item or short depression-screening measures are comparable to a comprehensive screening measure in reliability (i.e., internal consistency and test–retest reliability) and validity (i.e., convergent, concurrent, and predictive validity) in Korean young adults within a Classical Testing Theory framework.MethodA total of 458 students from six nursing colleges in South Korea completed three depression measures: the 20-item Center for Epidemiologic Studies-Depression screening instrument (CES-D; comprehensive measure); the five-item Profile of Mood States-Brief depression subscale (POMS-B depression subscale; short measure); a single-item Likert measure; and a single-item numeric rating scale. Internal consistency reliability was tested by Cronbach's alpha and item-total correlations; test–retest reliability by intraclass correlation coefficient (ICC); convergent validity by correlation with the CES-D; concurrent validity by the correlation with perceived stress level and sleep quality; and predictive validity by receiver operating characteristic curve to predict the two groups with different depression levels.ResultsThe POMS-B depression subscale was comparable to the comprehensive CES-D scale in internal consistency reliability (alpha = .85); test–retest reliability (ICC = .76); and convergent (r = .81 with CES-D), concurrent (r = .64 with perceived stress level, r = .34 with sleep quality), and predictive validity (area under the curve = .88). The two single-item options were not comparable to the comprehensive CES-D.ConclusionThe short POMS-B depression subscale shows an acceptable balance between practical clinical and research needs and psychometric quality.     

Validation of a French version of Roland–Morris questionnaire in chronic low back pain patients

ObjectiveTo validate a French version of the Roland–Morris Disability Questionnaire (RMDQ) in patients with chronic low back pain (LBP).Material and methodsFifty-eight patients due to participate in a functional rehabilitation programme for chronic low back pain were included prospectively. The RMDQ, the Quebec Back Pain Disability Scale (QBPDS) and the “daily activities” subscale of the Dallas Pain Questionnaire (DPQ) were administered. The RMDQ was assessed for internal consistency, reliability, criterion validity and sensitivity to change.ResultsCronbach's alpha for the RMDQ was 0.84. The intraclass correlation coefficient [95% confidence interval] was 0.89 [0.83–0.93]. The RMDQ score was correlated with the QBPDS score (r = 0.713) and the DPQ's “daily activities” subscore (r = 0.514). The results of assessments before and after functional rehabilitation showed that the French version of the RMDQ had very high sensitivity to change (effect size: 1.49) and was more sensitive than the QBPDS and the DPQ's “daily activities” subscore.ConclusionsOur study validated the French version of the RMDQ in patients suffering from chronic low back pain. Furthermore, we highlighted the questionnaire's very high sensitivity to change.     

Neuropathic Pain in Breast Cancer Survivors: Using the ID Pain as a Screening Tool

Neuropathic pain (NP) is a debilitating symptom experienced by a number of patients with cancer. We evaluated the validity of ID Pain as a screening tool for NP in breast cancer survivors using the Self-Report Leeds Assessment of Neuropathic Symptoms and Signs (S-LANSS) and a reported diagnosis of NP as criterion measures. Two hundred forty breast cancer survivors with a mean age of 58 years (standard deviation = 16) participated in this survey. Forty-five percent of the sample reported having pain in the past week. Of those reporting pain, 33% reported that they had been diagnosed by their health care provider with NP, 39% had a positive ID Pain (≥2) score, and 19% had a positive S-LANSS score. The most commonly endorsed ID Pain item was “hot/burning” (n = 48) followed by feeling “numb” (n = 47) and “pins and needles” (n = 45). Total ID Pain score was significantly associated with a clinical diagnosis of NP (r = 0.41; P < 0.001) and the S-LANSS total score (r = 0.54; P < 0.001). Receiver operating curve analysis demonstrated that ID Pain has a predictive validity of 0.72 and 0.70 for diagnosis of NP as made by clinicians and the S-LANSS, respectively. We also found that an ID Pain score greater than or equal to 2 corresponded with the likelihood of NP in this sample, consistent with the original ID Pain development study. This study provides evidence for ID Pain as a valid screening measure for NP in breast cancer survivors.     

A Comparison of Two Spirituality Instruments and Their Relationship With Depression and Quality of Life in Chronic Heart Failure

Spirituality is a multifaceted construct related to health outcomes that remains ill defined and difficult to measure. Spirituality in patients with advanced chronic illnesses, such as chronic heart failure, has received limited attention. We compared two widely used spirituality instruments, the Functional Assessment of Chronic Illness Therapy—Spiritual Well-Being (FACIT-Sp) and the Ironson-Woods Spirituality/Religiousness Index (IW), to better understand what they measure in 60 outpatients with chronic heart failure. We examined how these instruments related to each other and to measures of depression and quality of life using correlations and principal component analyses. The FACIT-Sp measured aspects of spirituality related to feelings of peace and coping, whereas the IW measured beliefs, coping, and relational aspects of spirituality. Only the FACIT-Sp Meaning/Peace subscale consistently correlated with depression (r = ?0.50, P < 0.0001) and quality of life (r = 0.41, P = 0.001). Three items from the depression measure loaded onto the same factor as the FACIT-Sp Meaning/Peace subscale (r = 0.43, ?0.43, and 0.71), whereas the remaining 12 items formed a separate factor (Cronbach's alpha = 0.82) when combined with the spirituality instruments in a principal component analysis. The results demonstrate several clinically useful constructs of spirituality in patients with heart failure and suggest that psychological and spiritual well-being, despite some overlap, remain distinct phenomena.     

Relationships between pain thresholds,catastrophizing and gender in acute whiplash injury

The mechanisms underlying sensory hypersensitivity (SH) in acute whiplash associated disorders (WAD) are not well understood. We examined the extent of the relationships between the sensory measures of pressure pain threshold (PPT) and cold pain threshold (CPT), catastrophizing, pain and disability levels and gender in acute WAD. Thirty-seven subjects reporting neck pain following a motor vehicle accident were examined within five weeks post-injury. Measures of neck pain and disability (Neck Disability Index, NDI) and catastrophizing (Pain Catastrophizing Scale, PCS) were taken. CPT was assessed in the cervical spine and PPTs were assessed in the cervical spine (PPTcx) and at a remote site (PPTdistal). CPT and PCS were moderately correlated (r = 0.46; p < 0.01); however there were no significant relationships between PPT (cervical and distal) and PCS. Both CPT (r = 0.55, p < 0.01) and PPTcx (r = ?0.42, p < 0.01) were significantly correlated with NDI but PPTdistal was not (r = ?0.08, p = 0.65). Finally, gender modulated the relationships between sensory measures, catastrophizing, and pain and disability levels. In conclusion, subjects with higher levels of catastrophizing presented with sensory hypersensitivity to cold stimuli in the acute phase of whiplash. Differences between genders are in accordance with the growing body of evidence suggesting that the relationships between some psychological factors and injury-related symptoms are modulated by gender.     

Consistent and Breakthrough Pain in Diverse Advanced Cancer Patients: A Longitudinal Examination

Although cancer pain, both consistent and breakthrough pain ([BTP]; pain flares interrupting well-controlled baseline pain), is common among cancer patients, its prevalence, characteristics, etiology, and impact on health-related quality of life (HRQOL) are poorly understood. This longitudinal study examined the experience and treatment of cancer-related pain over six months, including an evaluation of ethnic differences. Patients with Stage III or IV breast, prostate, colorectal, or lung cancer, or Stage II–IV multiple myeloma with BTP completed surveys on initial assessment and at three and six months. Each survey assessed consistent pain, BTP, depressed affect, active coping ability, and HRQOL. Among the respondents (n = 96), 70% were white, 66% were female, and had a mean age of 56 ± 10 years. Nonwhites reported significantly greater severity for consistent pain at its worst (P = 0.009), least (P ≤ 0.001), on average (P = 0.004), and upon initial assessment (P = 0.04), and greater severity for BTP at its worst (P = 0.03), least (P = 0.02), and at initial assessment (P = 0.008). Women also had higher levels of some BTP measures. Ethnic disparities persisted when data estimation techniques were used. Examined longitudinally, consistent pain on average and several BTP measures reduced over time, although not greatly, indicating the persistence of pain in the cancer experience. These data provide evidence for the significant toll of cancer pain, while demonstrating further health care disparities in the cancer pain experience.     

The immediate effects of foot orthoses on hip and knee kinematics and muscle activity during a functional step-up task in individuals with patellofemoral pain

BackgroundEvidence shows that anti-pronating foot orthoses improve patellofemoral pain, but there is a paucity of evidence concerning mechanisms. We investigated the immediate effects of prefabricated foot orthoses on (i) hip and knee kinematics; (ii) electromyography variables of vastus medialis oblique, vastus lateralis and gluteus medius during a functional step-up task, and (iii) associated clinical measures.MethodsHip muscle activity and kinematics were measured during a step-up task with and without an anti-pronating foot orthoses, in people (n = 20, 9 M, 11 F) with patellofemoral pain. Additionally, we measured knee function, foot posture index, isometric hip abductor and knee extensor strength and weight-bearing ankle dorsiflexion.FindingsReduced hip adduction (0.82°, P = 0.01), knee internal rotation (0.46°, P = 0.03), and decreased gluteus medius peak amplitude (0.9 mV, P = 0.043) were observed after ground contact in the ‘with orthoses’ condition. With the addition of orthoses, a more pronated foot posture correlated with earlier vastus medialis oblique onset (r = − 0.51, P = 0.02) whilst higher Kujala scores correlated with earlier gluteus medius onset (r = 0.52, P = 0.02).InterpretationAlthough small in magnitude, reductions in hip adduction, knee internal rotation and gluteus medius amplitude observed immediately following orthoses application during a task that commonly aggravates symptoms, offer a potential mechanism for their effectiveness in patellofemoral pain management. Given the potential for cumulative effects of weight bearing repetitions completed with a foot orthoses, for example during repeated stair ascent, the differences are likely to be clinically meaningful.     

Effects of a Full-Body Massage on Pain Intensity,Anxiety, and Physiological Relaxation in Taiwanese Patients with Metastatic Bone Pain: A Pilot Study

Bone involvement, a hallmark of advanced cancer, results in intolerable pain, substantial morbidity, and impaired quality of life in 34%–45% of cancer patients. Despite the publication of 15 studies on massage therapy (MT) in cancer patients, little is known about the longitudinal effects of MT and safety in cancer patients with bone metastasis. The purpose of this study was to describe the feasibility of MT and to examine the effects of MT on present pain intensity (PPI), anxiety, and physiological relaxation over a 16- to 18-hour period in 30 Taiwanese cancer patients with bone metastases. A quasi-experimental, one-group, pretest-post-test design with repeated measures was used to examine the time effects of MT using single-item scales for pain (PPI-visual analog scale [VAS]) and anxiety (anxiety-VAS), the modified Short-Form McGill Pain Questionnaire (MSF-MPQ), heart rate (HR), and mean arterial pressure (MAP). MT was shown to have effective immediate [t(29) = 16.5, P = 0.000; t(29) = 8.9, P = 0.000], short-term (20–30 minutes) [t(29) = 9.3, P = 0.000; t(29) = 10.1, P = 0.000], intermediate (1–2.5 hours) [t(29) = 7.9, P = 0.000; t(29) = 8.9, P = 0.000], and long-term benefits (16–18 hours) [t(29) = 4.0, P = 0.000; t(29) = 5.7, P = 0.000] on PPI and anxiety. The most significant impact occurred 15 [F = 11.5(1,29), P < 0.002] or 20 [F = 20.4(1,29), P < 0.000] minutes after the intervention. There were no significant time effects in decreasing or increasing HR and MAP. No patient reported any adverse effects as a result of MT. Clinically, the time effects of MT can assist health care providers in implementing MT along with pharmacological treatment, thereby enhancing cancer pain management. Randomized clinical trials are needed to validate the effectiveness of MT in this cancer population.     

Measuring the expressed emotion in Chinese family caregivers of persons with dementia: Validation of a Chinese version of the Family Attitude Scale

BackgroundExpressed emotion (EE) captures the affective quality of the relationship between family caregivers and their care recipients and is known to increase the risk of poor health outcomes for caregiving dyads. Little is known about expressed emotion in the context of caregiving for persons with dementia, especially in non-Western cultures. The Family Attitude Scale (FAS) is a psychometrically sound self-reporting measure for EE. Its use in the examination of caregiving for patients with dementia has not yet been explored.ObjectivesThis study was performed to examine the psychometric properties of the Chinese version of the FAS (FAS-C) in Chinese caregivers of relatives with dementia, and its validity in predicting severe depressive symptoms among the caregivers.MethodsThe FAS was translated into Chinese using Brislin's model. Two expert panels evaluated the semantic equivalence and content validity of this Chinese version (FAS-C), respectively. A total of 123 Chinese primary caregivers of relatives with dementia were recruited from three elderly community care centers in Hong Kong. The FAS-C was administered with the Chinese versions of the 5-item Mental Health Inventory (MHI-5), the Zarit Burden Interview (ZBI) and the Revised Memory and Behavioral Problem Checklist (RMBPC).ResultsThe FAS-C had excellent semantic equivalence with the original version and a content validity index of 0.92. Exploratory factor analysis identified a three-factor structure for the FAS-C (hostile acts, criticism and distancing). Cronbach's alpha of the FAS-C was 0.92. Pearson's correlation indicated that there were significant associations between a higher score on the FAS-C and greater caregiver burden (r = 0.66, p < 0.001), poorer mental health of the caregivers (r = −0.65, p < 0.001) and a higher level of dementia-related symptoms (frequency of symptoms: r = 0.45, p < 0.001; symptom disturbance: r = 0.51, p < 0.001), which serves to suggest its construct validity. For detecting severe depressive symptoms of the family caregivers, the receiving operating characteristics (ROC) curve had an area under curve of 0.78 (95% confidence interval (CI) = 0.69–0.87, p < 0.0001). The optimal cut-off score was >47 with a sensitivity of 0.720 (95% CI = 0.506–0.879) and specificity of 0.742 (95% CI = 0.643–0.826).ConclusionsThe FAS-C is a reliable and valid measure to assess the affective quality of the relationship between Chinese caregivers and their relatives with dementia. It also has acceptable predictability in identifying family caregivers with severe depressive symptoms.     

Crenobalneotherapy (spa therapy) in patients with knee and generalized osteoarthritis: A post-hoc subgroup analysis of a large multicentre randomized trial

ObjectiveTo determine whether the addition of spa therapy to home exercises provides any benefit over exercises and the usual treatment alone in the management of generalised osteoarthritis associated with knee osteoarthritis.MethodsThis study was a post-hoc subgroup analysis of our randomised multicentre trial (www.clinicaltrial.gov: NCT00348777). Participants who met the inclusion criteria of generalized osteoarthritis (Kellgren, American College of Rheumatology, or Dougados criteria) were extracted from the original randomised controlled trial. They had been randomised using Zelen randomisation. The treatment group received 18 days of spa treatment in addition to a home exercise programme. Main outcome was number of patients achieving minimal clinically important improvement at six months (MCII) (≥ −19.9 mm on the VAS pain scale and/or ≥ −9.1 points in a WOMAC function subscale), and no knee surgery. Secondary outcomes included the “patient acceptable symptom state” (PASS) defined as VAS pain ≤ 32.3 mm and/or WOMAC function subscale ≤ 31 points.ResultsFrom the original 462 participants, 214 patients could be categorized as having generalised osteoarthritis. At sixth month, 182 (88 in control and 94 in SA group) patients, were analysed for the main criteria. MCII was observed more often in the spa group (n = 52/94 vs. 38/88, P = 0.010). There was no difference for the PASS (n = 19/88 vs. 26/94, P = 0.343).ConclusionsThis study indicates that spa therapy with home exercises may be superior to home exercise alone in the management of patients with GOA associated with knee OA.     

Correlations between ankle–foot impairments and dropped foot gait deviations among stroke survivors

BackgroundThe purpose of this paper is to 1) evaluate the relationship between ankle kinematics during gait and standardized measures of ankle impairments among sub-acute stroke survivors, and 2) compare the degree of stroke-related ankle impairment between individuals with and without dropped foot gait deviations.MethodsFifty-five independently ambulating stroke survivors participated in this study. Dropped foot was defined as decreased peak dorsiflexion during the swing phase and reduced ankle joint motion in stance. Standardized outcome measures included the Chedoke–McMaster Stroke Assessment (motor impairment), Modified Ashworth Scale (spasticity), Medical Research Council (muscle strength), passive and active range of motion, and isometric muscle force.FindingsFoot impairment was not related to peak dorsiflexion during swing (r = ? 0.17, P = 0.247) and joint motion during stance (r = 0.05, P = 0.735). Active (r = 0.45, P < 0.001) and passive (r = 0.48, P < 0.001) range of motion was associated with stance phase joint motion. Peak dorsiflexion during swing was related to isometric dorsiflexor muscle force (r = ? 0.32, P = 0.039). Individuals with dropped foot demonstrated greater motor impairment, plantarflexor spasticity and ankle muscle weakness compared to those without dropped foot.InterpretationOur investigation suggests that ankle–foot impairments are related to ankle deviations during gait, as indicated by greater impairment among individuals with dropped foot. These findings contribute to a better understanding of gait-specific ankle deviations, and may lead to the development of a more effective clinical assessment of dropped foot impairment.     

A Comparison of Quality-of-Life Domains and Clinical Factors in Ovarian Cancer Patients: A Gynecologic Oncology Group Study

ContextWomen diagnosed with ovarian cancer are at risk for reduced quality of life (QOL). It is imperative to further define these declines to interpret treatment outcomes and design appropriate clinical interventions.ObjectivesThe primary objective of this study was to compare data obtained from ovarian cancer patients with normative data to assess the degree to which QOL differs from the norm. Secondary objectives were to examine demographic variables and determine if there was a correlation between physical/functional and social/emotional scores during chemotherapy.MethodsPatients with Stage III/IV ovarian cancer on Gynecologic Oncology Group Protocols 152 and 172 who underwent surgery followed by intravenous paclitaxel and cisplatin completed the Functional Assessment of Cancer Therapy-Ovarian. The Functional Assessment of Cancer Therapy scale includes the four domains of physical, functional, social, and emotional well-being (PWB, FWB, SWB, and EWB, respectively).ResultsOvarian cancer patients had a total QOL (Functional Assessment of Cancer Therapy-General) score similar to the U.S. female adult population. However, the reported subscale scores were 2.0 points (95% confidence interval [CI] 1.4–2.5, P < 0.001, effect size = 0.37) lower in PWB, 0.9 points (95% CI 0.3–1.5, P = 0.005, effect size = 0.13) lower in FWB, 5.0 points (95% CI 4.6–5.3, P < 0.001, effect size = 0.74) higher in SWB, and 0.8 points (95% CI 0.3–1.2, P < 0.001, effect size = 0.16) lower in EWB. Correlation between the sum of PWB and FWB and the sum of SWB and EWB was r = 0.53 (P < 0.001). Age was positively correlated with EWB (r = 0.193; 95% CI 0.09–0.29).ConclusionOvarian cancer patients have decreased QOL in physical, functional, and emotional domains; however, they may compensate with increased social support. At the time of diagnosis and treatment, patients' QOL is affected by inherent characteristics. Assessment of treatment outcomes should take into account the effect of these independent variables.     

Clinician-reported lesion measurements in skin infection trials: Definitions,reliability, and association with patient-reported pain

ObjectivesOutcome assessments as clinical trial endpoints should be well-defined, reliable, and reflect meaningful treatment benefits. For acute bacterial skin and skin structure infections (ABSSSI) trials, recent recommendations suggest a primary endpoint of reduction in skin lesion area. Objectives were: evaluate ABSSSI lesion area measurement reliability, evaluate impact of various lesion area definitions on treatment effect size, and explore relationships between lesion area and pain.MethodsData from two randomized, double-blinded Phase 3 trials comparing tedizolid to linezolid in ABSSSI and one open-label, non-comparative Phase 2 study of tedizolid in cellulitis/erysipelas and skin abscess were analyzed. Repeated lesion area measurements were prospectively obtained in all studies. In the open-label study, lesion area was measured by two investigators, using four different definitions. Repeated pain assessments using two patient-reported outcome instruments (Visual Analog Scale [VAS] and Faces Rating Scale [FRS]) were elicited in the randomized trials.ResultsAt baseline, lesion size did not correlate with pain intensity: r = 0.02 for VAS and r < 0.01 for FRS pain scores. However, decreasing lesion size and decreasing pain were strongly associated over time, regardless of initial lesion size or pain intensity (r = 0.20 for VAS and r = 0.21 for FRS scores at Day 10–13). Each lesion area definition demonstrated high inter-observer reliability (intra-class correlation coefficient > 0.95).ConclusionsDecreasing lesion area (indirect clinician-reported measure of benefit) and pain (direct patient-reported measure of benefit) were strongly associated over time, and lesion area measurements were reliable, regardless of their definition. These findings support both measures as outcome assessments in ABSSSI clinical trials.RegistrationClinicaltrials.govNCT01519778, NCT01170221, and NCT01421511.     

Evolution of Cancer-Related Symptoms Over an 18-Month Period

ContextPrevious studies have revealed inconsistent findings about the longitudinal evolution of cancer-related symptoms. In addition, the contribution of medical factors (e.g., cancer site, and treatments) in explaining the changes in these symptoms is yet to be established.ObjectivesThis prospective study investigated longitudinal changes of five symptoms (i.e., depression, anxiety, insomnia, fatigue, and pain) in patients scheduled to undergo surgery for cancer (N = 828).MethodsThe patients completed the Hospital Anxiety and Depression Scale, the Insomnia Severity Index, the Multidimensional Fatigue Inventory, and a pain questionnaire at baseline and after 2, 6, 10, 14 and 18 months.ResultsSeveral time changes were statistically significant but effect sizes only revealed one change of a medium magnitude, that is, a reduction of anxiety from T1 to T2 (d = ?0.58). Women with breast or gynecological cancer were the only subgroups to exhibit significant changes (i.e., reduction of a small magnitude of anxiety symptoms from T1 to T2; ds = ?0.27 and ?0.30, respectively). However, numerous differences were found across adjuvant treatments, including greater variations in depression and insomnia scores in the chemotherapy group (ds = ?0.71 to 0.20) and a transient increase in fatigue symptoms in patients receiving “all” adjuvant treatments (ds = ?0.24 to 0.37).ConclusionThe severity of cancer-related symptoms varies during the cancer care trajectory, especially anxiety scores, which importantly decrease during the first few months after the surgery. This study also suggests that treatment regimens better account for individual differences than cancer site in the evolution of symptoms.     

Validation of an Arabic version of the Oswestry index in Saudi Arabia

ObjectiveThe aim of this study was to adapt and validate the Tunisian version of the Oswestry Disability Index (ODI) within a Saudi Arabian population.MethodThe translation of items 8 and 10 taken out of the Tunisian version was conducted according to Beaton's method. Adaptations were made after a pilot study on 100 patients. The validation study included 100 patients suffering from chronic low back pain aged 18 to 65 years old. Intra-observer reliability was assessed using the intra-class coefficient (ICC). Spearman rank correlation coefficient, the Kruskall–Wallis test and factor analysis were used to evaluate construct validity (convergent and divergent validity). Internal consistency was assessed by Cronbach's alpha coefficient.ResultsOne hundred Saudi patients were included in the study. Intra-observer reliability was excellent (ICC: 0.99). The correlations of the index with the VAS pain scale (r = 0.708), the Roland–Morris Low Back Pain Disability (r = 0.656), and the Quebec Back Pain Disability Scale (r = 0.792) suggest good construct validity. Factor analysis unveiled two main factors explaining a cumulative percentage variance of 63.5%. The first factor represents static activities and the second factor represents dynamic activities.ConclusionThe Arabic version of the ODI adapted to the Saudi population has high metrological qualities. Further studies assessing its responsiveness to change should be conducted.     

Nurse practitioner led pain management the day after caesarean section: A randomised controlled trial and follow-up study

BackgroundPain on the day after caesarean section is often treated with controlled-release oxycodone to supplement the decline in analgesia from intrathecal opioids. Evidence suggests that caesarean birth is a biopsychosocial experience where a comprehensive approach is needed that promotes control and participation in pain management.ObjectivesThis study compared immediate-release oxycodone integrated with supportive educational strategies to controlled-release oxycodone. A follow-up phase aimed to explore pain over three months.DesignThis study was a two-group parallel randomised controlled trial.SettingA metropolitan hospital in Australia with a birthing suite, operating rooms, and a postnatal unit.ParticipantsEnglish-speaking women scheduled for elective caesarean section were mailed trial information. Exclusion criteria included contraindications to intrathecal analgesia, herpes simplex infection, a history of chronic pain, opioid tolerance, or substance abuse. A total of 131 participants were recruited and randomised out of 298 eligible participants.MethodsGroup allocation was undertaken using sequentially numbered opaque sealed envelopes. The nurse practitioner intervention commenced on the day after surgery with immediate-release oxycodone alongside supportive strategies. The control group received scheduled doses of controlled-release oxycodone. All participants could request additional oxycodone or tramadol. Primary outcomes were pain intensity and secondary outcomes included patient global impression of change, pain interference, opioid consumption, and maternal perception of control. A follow-up phase evaluated pain outcomes over three months.ResultsThe final sample size was 122, with 61 participants in each group. Pain intensity scores were analysed by linear mixed regression models. There were no statistical differences over 24 h between the control and intervention groups at rest (p = 0.40, 95% CI – 4.8 mm, 11.9 mm) or on sitting or moving (p = 0.561, 95% CI –15.2 mm, 8.3 mm). Patient global impression of change was significant over three hours (p = 0.014, OR = 2.5, 95% CI 1.2, 5.3). The intervention group reported less pain interference while consuming less oxycodone (p < 0.05). There was no difference between groups in terms of perceived control over pain management (p = 0.273, 95% CI –16.2 mm, 4.6 mm). The follow-up analysis graded 5.9% of participants as experiencing severe pain interference. Chronic pain following caesarean was associated with postnatal depression (p < 0.001).ConclusionsThe research showed that a nurse practitioner intervention can improve pain management following caesarean section. The results underscore the influence of biological, psychological, and social factors on acute pain. Hence, this study reinforces the need for a biopsychosocial approach to acute pain management following caesarean delivery.