Automated Telephone System Research Articles

Feasibility of a culturally adapted technology-delivered, family-based childhood obesity intervention for Latino/Hispanic families in rural Nebraska: the Hispanic Family Connections study protocol

IntroductionAddressing childhood obesity risk factors like home environment, parental roles, excess weight, physical activity and healthy eating among Latino/Hispanic (L/H) families living in rural communities is an important priority. However,...

Effect of Electronic Symptom Monitoring on Patient-Reported Outcomes Among Patients With Metastatic Cancer

Electronic systems that facilitate patient-reported outcome (PRO) surveys for patients with cancer may detect symptoms early and prompt clinicians to intervene. To evaluate whether electronic symptom monitoring during cancer treatment confers benefits on quality-of-life outcomes. Report of secondary outcomes from the PRO-TECT (Alliance AFT-39) cluster randomized trial in 52 US community oncology practices randomized to electronic symptom monitoring with PRO surveys or usual care. Between October 2017 and March 2020, 1191 adults being treated for metastatic cancer were enrolled, with last follow-up on May 17, 2021. In the PRO group, participants (n = 593) were asked to complete weekly surveys via an internet-based or automated telephone system for up to 1 year. Severe or worsening symptoms triggered care team alerts. The control group (n = 598) received usual care. The 3 prespecified secondary outcomes were physical function, symptom control, and health-related quality of life (HRQOL) at 3 months, measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ-C30; range, 0-100 points; minimum clinically important difference [MCID], 2-7 for physical function; no MCID defined for symptom control or HRQOL). Results on the primary outcome, overall survival, are not yet available. Among 52 practices, 1191 patients were included (mean age, 62.2 years; 694 [58.3%] women); 1066 (89.5%) completed 3-month follow-up. Compared with usual care, mean changes on the QLQ-C30 from baseline to 3 months were significantly improved in the PRO group for physical function (PRO, from 74.27 to 75.81 points; control, from 73.54 to 72.61 points; mean difference, 2.47 [95% CI, 0.41-4.53]; P = .02), symptom control (PRO, from 77.67 to 80.03 points; control, from 76.75 to 76.55 points; mean difference, 2.56 [95% CI, 0.95-4.17]; P = .002), and HRQOL (PRO, from 78.11 to 80.03 points; control, from 77.00 to 76.50 points; mean difference, 2.43 [95% CI, 0.90-3.96]; P = .002). Patients in the PRO group had significantly greater odds of experiencing clinically meaningful benefits vs usual care for physical function (7.7% more with improvements of ≥5 points and 6.1% fewer with worsening of ≥5 points; odds ratio [OR], 1.35 [95% CI, 1.08-1.70]; P = .009), symptom control (8.6% and 7.5%, respectively; OR, 1.50 [95% CI, 1.15-1.95]; P = .003), and HRQOL (8.5% and 4.9%, respectively; OR, 1.41 [95% CI, 1.10-1.81]; P = .006). In this report of secondary outcomes from a randomized clinical trial of adults receiving cancer treatment, use of weekly electronic PRO surveys to monitor symptoms, compared with usual care, resulted in statistically significant improvements in physical function, symptom control, and HRQOL at 3 months, with mean improvements of approximately 2.5 points on a 0- to 100-point scale. These findings should be interpreted provisionally pending results of the primary outcome of overall survival. ClinicalTrials.gov Identifier: NCT03249090.

Digital symptom monitoring with patient-reported outcomes in community oncology practices: A U.S. national cluster randomized trial.

349527 Background: Symptoms are common during cancer care but often go undetected. Digital systems that elicit patient-reported outcomes (PRO) surveys may detect symptoms early and prompt clinicians to intervene, thereby alleviating suffering and averting complications. Methods: In a cluster-randomized trial, U.S.-based community oncology practices were randomized 1:1 to digital symptom monitoring with PRO surveys, or to usual care control. Patients receiving systemic treatment for metastatic cancer were eligible. At PRO practices, participants were invited to complete a weekly survey via web or automated telephone system for up to one year, including questions about nine common symptoms, performance status, and falls. Severe or worsening symptoms triggered electronic alerts to care team nurses, and reports showing longitudinal symptom data were available to oncologists at visits. Pre-specified secondary outcomes included impact on physical function, symptom control, and health-related quality of life (HRQL). The primary outcome of survival is not yet mature. Results: At 52 practices, 1,191 patients were eligible and enrolled (593 PRO; 598 control). Clinically meaningful benefits were experienced in physical function by 13.8% more patients with PRO versus control (P=0.009); symptom control by 16.1% (P=0.003); and HRQL by 13.4% (P=0.006). Mean changes from baseline were superior with PRO versus control for physical function (mean difference 2.47, 95% CI 0.41-4.53; P=0.02), symptom control (2.56, 0.95-4.17; P=0.002), and HRQL (2.43, 0.90-3.96; P=0.002). Patients completed 20,565/22,486 (91.5%) of expected weekly PRO surveys. Conclusions: Digital symptom monitoring during cancer treatment confers clinical benefits. Clinical trial information: NCT03249090.

Hospice Family Caregivers’ Use of Audio Diaries

Previous work has shown that emotional processing as part of diary writing improves well-being during and after stress. The purpose of this study was to determine the feasibility of verbal/audio diaries for home hospice family caregivers (HFCGs). We also describe diary content. As part of an ongoing multi-site, prospective longitudinal study, HFCGs of cancer patients report daily fluctuations in patients’ and their own symptoms via an automated telephone system, including a recorded diary entry. HFCGs are randomly assigned instructions to either discuss additional symptoms or discuss their thoughts and feelings. Thirty-six (85.7%) participants to date have completed at least one audio diary. For this preliminary analysis, we selected the 14 longest diary recordings from each condition (n=28) to content analyze using Linguistic Inquiry and Word Count (LIWC) and NVivo 12. Participants are 78.6% female, 53 years of age on average, and most are spouse/partner (46.4%) or adult child (35.7%) caregivers. There was no difference in the overall positivity (23%) or negativity (77%) of words in either condition, but participants asked to express thoughts/feelings used significantly more anger-related terms (p=0.04) while those asked to describe symptoms used significantly more anxiety-related terms (p = 0.003). Time was the most common theme in both conditions but arose more frequently in the symptom condition (p=.08). Our findings suggest that most audio diaries are feasible for HFCGs, but varied prompts may facilitate different types of emotional expression. Future research should assess potential impact on emotional well-being and bereavement adjustment.

Clinical Utility and User Perceptions of a Digital System for Electronic Patient-Reported Symptom Monitoring During Routine Cancer Care: Findings From the PRO-TECT Trial.

There is increasing interest in implementing digital systems for remote monitoring of patients' symptoms during routine oncology practice. Information is limited about the clinical utility and user perceptions of these systems. PRO-TECT is a multicenter trial evaluating implementation of electronic patient-reported outcomes (ePROs) among adults with advanced and metastatic cancers receiving treatment at US community oncology practices (ClinicalTrials.gov identifier: NCT03249090). Questions derived from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) are administered weekly by web or automated telephone system, with alerts to nurses for severe or worsening symptoms. To elicit user feedback, surveys were administered to participating patients and clinicians. Among 496 patients across 26 practices, the majority found the system and questions easy to understand (95%), easy to use (93%), and relevant to their care (91%). Most patients reported that PRO information was used by their clinicians for care (70%), improved discussions with clinicians (73%), made them feel more in control of their own care (77%), and would recommend the system to other patients (89%). Scores for most patient feedback questions were significantly positively correlated with weekly PRO completion rates in both univariate and multivariable analyses. Among 57 nurses, most reported that PRO information was helpful for clinical documentation (79%), increased efficiency of patient discussions (84%), and was useful for patient care (75%). Among 39 oncologists, most found PRO information useful (91%), with 65% using PROs to guide patient discussions sometimes or often and 65% using PROs to make treatment decisions sometimes or often. These findings support the clinical utility and value of implementing digital systems for monitoring PROs, including the PRO-CTCAE, in routine cancer care.

Feasibility of Implementing the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events in a Multicenter Trial: NCCTG N1048.

Purpose The US National Cancer Institute (NCI) Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) was developed to enable patient reporting of symptomatic adverse events in oncology clinical research. This study was designed to assess the feasibility and resource requirements associated with implementing PRO-CTCAE in a multicenter trial. Methods Patients with locally advanced rectal cancer enrolled in the National Cancer Institute-sponsored North Central Cancer Treatment Group (Alliance) Preoperative Radiation or Selective Preoperative Radiation and Evaluation before Chemotherapy and Total Mesorectal Excision trial were asked to self-report 30 PRO-CTCAE items weekly from home during preoperative therapy, and every 6 months after surgery, via either the Web or an automated telephone system. If participants did not self-report within 3 days, a central coordinator called them to complete the items. Compliance was defined as the proportion of participants who completed PRO-CTCAE assessments at expected time points. Results The prespecified PRO-CTCAE analysis was conducted after the 500th patient completed the 6-month follow-up (median age, 56 years; 33% female; 12% nonwhite; 43% high school education or less; 5% Spanish speaking), across 165 sites. PRO-CTCAE was reported by participants at 4,491 of 4,882 expected preoperative time points (92.0% compliance), of which 3,771 (77.2%) were self-reported by participants and 720 (14.7%) were collected via central coordinator backup. Compliance at 6-month post-treatment follow-up was 333 of 468 (71.2%), with 122 (26.1%) via backup. Site research associates spent a median of 15 minutes on PRO-CTCAE work for each patient visit. Work by a central coordinator required a 50% time commitment. Conclusion Home-based reporting of PRO-CTCAE in a multicenter trial is feasible, with high patient compliance and low site administrative requirements. PRO-CTCAE data capture is improved through centralized backup calls.

Implementation of Patient-Reported Outcomes in Routine Medical Care.

There is increasing interest to integrate collection of patient-reported outcomes (PROs) in routine practice to enhance clinical care. Multiple studies show that systematic monitoring of patients using PROs improves patient-clinician communication, clinician awareness of symptoms, symptom management, patient satisfaction, quality of life, and overall survival. The general approach includes a brief electronic survey, administered via the Web or an app or an automated telephone system, with alerts to clinicians for concerning or worsening issues. Patients have generally been asked to self-report on a regular basis (remotely between visits and/or at visits), with reminders prompting patients to self-report that are sent via email, text, or automated phone message. More recently, care management pathways for patients and clinicians have been triggered by PRO system alerts. PRO systems may be free-standing, integrated into electronic health record systems or patient portals, or native functionality of an electronic health record. Despite potential benefits, there are challenges with integrating PROs into practice for monitoring patient status, as there are with any modifications to existing clinical processes. These challenges range from administrative to technical to workflow. A session at the 2018 ASCO Annual Meeting was dedicated to the implementation of PROs in clinical practice. The session focused on practical examples of PRO implementations, with honest reflections on barriers and strategies that may be generalizable to other systems looking to implement PROs. Panelists for that session are the authors of this paper, which describes their respective experiences implementing PROs in practice settings.

Acceptability of a multilevel intervention to improve blood pressure control among patients with chronic kidney disease in a public health care delivery system.

BackgroundThe Kidney Awareness Registry and Education (KARE) trial examined the impact of a multilevel intervention on blood pressure control among patients with chronic kidney disease (CKD) in a public health care delivery system. KARE consisted of a clinic-based intervention (a primary care CKD registry with point-of-care provider notifications and quarterly feedback related to CKD management) and a patient-directed intervention [a CKD self-management support (CKD-SMS) program that included low literacy educational materials, automated telephone-administered self-management modules and telephone health coaching]. We explored the acceptability of these interventions among end users.MethodsAt trial conclusion, we surveyed 39 primary care providers (PCPs) to identify preferences about components of the clinic intervention, conducted two focus groups among non-PCP staff to elicit in-depth attitudes and experiences with operationalizing the team-based CKD registry, and conducted eight focus groups with English- and Spanish-speaking patients to hear about their experiences with the CKD-SMS program. Focus group transcripts were analyzed using thematic analysis. Self-reported participation and data from the automated telephone program were used to evaluate patient engagement.ResultsMost PCPs (94%) believed that the point-of-care notifications benefited clinic workflow and agreed that quarterly feedback enhanced their ability to identify (89.5%) and manage (73.7%) CKD. Staff confirmed usefulness of point-of-care notifications. Patients suggested the automated telephone system was impersonal, though easy to use; that frequent automated calls were helpful to reinforce self-management behaviors; and that telephone health coaching was convenient. Nearly 40% of patients completed >80% of automated phone calls, 95% participated in calls with their health coach and 77% created at least one action plan.ConclusionsA CKD registry is acceptable to primary care health care teams and has potential to enhance identification and management of CKD in primary care. Low-income patients appreciated and engaged with a telephone-based CKD-SMS program, demonstrating its potential for increasing awareness and health engagement among populations with CKD within a public health care delivery system.

Use of an at-home multilevel pregnancy test and an automated telephone system to simplify medical abortion follow-up

Use of an at-home multilevel pregnancy test and an automated telephone system to simplify medical abortion follow-up

Children's Experiences Wearing Pedometers in a Telephone-Delivered Imagery Intervention Aimed at Increasing Active Play

Purpose: Much of what we know about pedometer interventions and imagery interventions with children is grounded in quantitative data. The general purpose of the present study was to qualitatively explore the experiences of children who had participated in a 4-week imagery intervention designed to increase active play. Specifically, the current study investigated children's experiences with (a) wearing pedometers and (b) listening to audio recordings (imagery scripts and short stories) via an automated telephone system. Method: Two focus-group interviews were conducted with a subsample of children (aged 9–10 years) who had completed the imagery intervention: 1 interview with children from the imagery group (n = 7) and 1 with children from the control group (n = 5). Results: Findings indicated that children enjoyed wearing pedometers. At the same time, children reported some complaints about wearing these devices (e.g., they are uncomfortable). Children also described that the automated telephone system was fun to use, despite the fact that it was difficult to remember to call the system 3 times each week. Finally, children in the imagery group noted that the imagery scripts were easy to imagine and motivated them to engage in active play, while children in the control group found the short stories interesting. Conclusion: The results of the current study can help researchers and practitioners develop and implement effective pedometer and imagery interventions with children.

The Association of Chemotherapy-Induced Peripheral Neuropathy Symptoms and the Risk of Falling.

Chemotherapy-induced peripheral neuropathy (CIPN) is a common adverse effect of neurotoxic chemotherapy resulting in pain, sensory loss, and decreased quality of life. Few studies have prospectively examined the relationship between sensory neuropathy symptoms, falls, and fall-related injuries for patients receiving neurotoxic chemotherapy. To determine the association between the symptoms of CIPN and the risk of falls for patients receiving neurotoxic chemotherapy. In this secondary analysis of a prospective study, 116 patients with breast, ovarian, or lung cancer who were beginning neurotoxic chemotherapy with a taxane or platinum agent were recruited from oncology clinics. These patients would call a novel automated telephone system daily for 1 full course of chemotherapy. The telephone system (SymptomCare@Home) used a series of relevant CIPN questions to track symptoms on a 0 to 10 ordinal scale and contained a questionnaire about falls. Those reporting a numbness and tingling severity score of 3 or greater for at least 10 days were considered to have significant CIPN symptoms and were compared with those patients who did not. Data analysis was performed in November 2015. Chemotherapy with a neurotoxic taxane or platinum agent. Patient-reported falls or near falls and fall-related injuries. The hypothesis was generated after data collection but prior to data analysis. Of the 116 patients who started neurotoxic chemotherapy (mean [SD] age was 55.5 [11.9] years, and 109 [94.0%] were female), 32 met the predetermined criteria for CIPN symptoms. The mean duration of follow-up was 62 days, with 51 telephone calls completed per participant. Seventy-four falls or near falls were reported. The participants with CIPN symptoms were nearly 3 times more likely to report a fall or near fall than the participants without CIPN symptoms (hazard ratio, 2.67 [95% CI, 1.62-4.41]; P < .001). The participants with CIPN symptoms were more likely than the participants without CIPN symptoms to obtain medical care for falls (8 of 32 participants with CIPN symptoms [25.0%] vs 6 of 84 participants without CIPN symptoms [7.1%]; P = .01). These findings suggest that the sensory symptoms of CIPN are an indicator of an increased risk of falling and an increased use of health care resources. This study demonstrates the utility of a novel telephone-based system to track neuropathy symptoms. Careful monitoring and coaching of patients receiving neurotoxic chemotherapy for new sensory symptoms may facilitate more effective fall prevention strategies.

Nutritional management of patients with diabetic peripheral neuropathy with L-methylfolate-methylcobalamin-pyridoxal-5-phosphate: results of a real-world patient experience trial

Objective:Current therapies for diabetic peripheral neuropathy with pain mask the painful symptoms while the underlying pathology continues to progress. This study assessed changes in symptoms and quality of life in patients taking a novel prescription medical food, L-methylfolate-methylcobalamin-pyridoxal-5-phosphate (LMF-MC-PP, Metanx), intended to address the underlying metabolic needs of patients with diabetic peripheral neuropathy.Research design and methods:Between November 2010 and April 2012, patients rated their experiences before and after using LMF-MC-PP through an automated telephone system that included symptomatic items from the Neuropathy Total Symptom Score-6 (NTSS-6) questionnaire and questions related to quality of life and medication satisfaction.Results:A total of 544 patients participated in the study. Patients reported a mean reduction of 35% in NTSS-6 scores from after 12 weeks on LMF-MC-PP. Mean (standard deviation) score was reduced by 1.5 (1.8) at 12 weeks from a baseline of 4.3 (1.5) (p < 0.05). Patients achieved significant reductions in self-reported disruptions in work/school activities, social life, and family life, respectively. Overall pain rating decreased by 32% (p < 0.05). Patients previously treated with medications reported a 52% improvement in medication satisfaction (p < 0.05).Conclusions:In a real-world clinical setting, patients with diabetic peripheral neuropathy treated with LMF-MC-PP achieved significant improvements in total symptom score (NTSS-6) and in quality of life and functioning, together with greater medication satisfaction. A limitation of this study was the use of a survey instrument to collect data on patient outcomes.

A web and telephone randomisation service in one hour – the benefits and challenges of delivering a configurable randomisation system

No two trials are the same; even from an IS perspective. From differing data collection approaches, through to the myriad trial reports required to support them, we know there will always be a role for IT specialists delivering bespoke solutions to support the development and delivery of clinical trials. When however in 2013 we focused on how we developed our randomisation services, we found that in the majority of cases they used a method of randomisation that could be broadly categorised into either minimisation or randomised permuted blocks. What we also knew was that we were spending a great deal of time and effort both developing and importantly validating these applications. In early 2014 this awareness combined with a growing clamour from our trial teams to deliver randomisation services over the web (previously we only supported an automated telephone system) drove us to rethink entirely our strategy for delivering randomisation. Could we build a single configurable system to meet the similar needs of our trial teams which still had the flexibility to deal with the unexpected? Could we harness a single configuration to deliver those services both over the web and the telephone? Could we harness this configurable system to reduce the development and validation burden, therefore allowing us to deliver these systems both more quickly and more efficiently?

Automated Outreach for Cardiovascular-Related Medication Refill Reminders.

The objective of this study was to evaluate the effectiveness of an automated telephone system reminding patients with hypertension and/or cardiovascular disease to obtain overdue medication refills. The authors compared the intervention with usual care among patients with an overdue prescription for a statin or lisinopril-hydrochlorothiazide (lisinopril-HCTZ). The primary outcome was refill rate at 2weeks. Secondary outcomes included time to refill and change in low-density lipoprotein cholesterol and blood pressure. Significantly more patients who received a reminder call refilled their prescription compared with the usual-care group (statin cohort: 30.3% vs 24.9% [P<.0001]; lisinopril-HCTZ cohort: 30.7% vs 24.2% [P<.0001]). The median time to refill was shorter in patients receiving the reminder call (statin cohort: 29 vs 36days [P<.0001]; lisinopril-HCTZ cohort: 24 vs 31days [P<.0001]). There were no statistically significant differences in mean low-density lipoprotein cholesterol and blood pressure. These findings suggest the need for interventions that have a longer-term impact.

Effect of tight control of inflammation in early psoriatic arthritis (TICOPA): a UK multicentre, open-label, randomised controlled trial

Early intervention and tight control of inflammation optimise outcomes in rheumatoid arthritis but these approaches have not yet been studied in psoriatic arthritis. We aimed to assess the effect of tight control on early psoriatic arthritis using a treat-to-target approach. For this open-label multicentre randomised controlled trial, adult patients (aged ≥18 years) with early psoriatic arthritis (<24 months symptom duration), who had not previously received treatment with any disease-modifying anti-rheumatic drugs, were enrolled from eight secondary care rheumatology centres in the UK. Enrolled patients were randomly assigned in a 1:1 ratio to receive either tight control (with review every 4 weeks and with escalation of treatment if minimal disease activity criteria not met) or standard care (standard therapy according to the treating clinician, with review every 12 weeks) for 48 weeks. Randomisation was done by minimisation incorporating a random element, to ensure treatment groups were balanced for randomising centre and pattern of arthritis (oligoarticular vs polyarticular). The randomisation procedure was done through a central 24-h automated telephone system based at the Leeds Institute of Clinical Trials Research (Leeds, UK). This was an open-label study in which patients and clinicians were aware of treatment group assignment. Clinical outcomes were recorded by a masked assessor every 12 weeks. The primary outcome was the proportion of patients achieving an American College of Rheumatology (ACR) 20% (ACR20) response at 48 weeks, analysed by intention to treat with multiple imputation for missing ACR components. Cost-effectiveness was also assessed. This trial is registered with ClinicalTrials.gov, number NCT01106079, and the ISCRCTN registry, number ISCRCTN30147736. Between May 28, 2008, and March 21, 2012, 206 eligible patients were enrolled and randomly assigned to receive tight control (n=101) or standard care (n=105). In the intention-to-treat patient population, the odds of achieving an ACR20 response at 48 weeks were higher in the tight control group than in the standard care group (odds ratio 1·91, 95% CI 1·03-3·55; p=0·0392). Serious adverse events were reported by 20 (10%) patients (25 events in 14 [14%] patients in the tight control group and eight events in six [6%] patients in the standard care group) during the course of the study. No unexpected serious adverse events or deaths occurred. Tight control of psoriatic arthritis disease activity through a treat-to-target approach significantly improves joint outcomes for newly diagnosed patients, with no unexpected serious adverse events reported. Arthritis Research UK and Pfizer.

Call Me, Maybe: Examining the Compliance Rates and Cost-effectiveness of a Participant-initiated Automated Telephone System with Children

Call Me, Maybe: Examining the Compliance Rates and Cost-effectiveness of a Participant-initiated Automated Telephone System with Children

To evaluate the sensitivity and specificity of the four validated psoriatic arthritis screening tools (TOPAS, PASE, PEST and EARP) in diagnosing Psoriatic Arthritis(PsA) in Indian patients with Psoriasis (PsO)

Early intervention and tight control of inflammation optimise outcomes in rheumatoid arthritis but these approaches have not yet been studied in psoriatic arthritis. We aimed to assess the effect of tight control on early psoriatic arthritis using a treat-to-target approach.For this open-label multicentre randomised controlled trial, adult patients (aged ≥18 years) with early psoriatic arthritis (<24 months symptom duration), who had not previously received treatment with any disease-modifying anti-rheumatic drugs, were enrolled from eight secondary care rheumatology centres in the UK. Enrolled patients were randomly assigned in a 1:1 ratio to receive either tight control (with review every 4 weeks and with escalation of treatment if minimal disease activity criteria not met) or standard care (standard therapy according to the treating clinician, with review every 12 weeks) for 48 weeks. Randomisation was done by minimisation incorporating a random element, to ensure treatment groups were balanced for randomising centre and pattern of arthritis (oligoarticular vs polyarticular). The randomisation procedure was done through a central 24-h automated telephone system based at the Leeds Institute of Clinical Trials Research (Leeds, UK). This was an open-label study in which patients and clinicians were aware of treatment group assignment. Clinical outcomes were recorded by a masked assessor every 12 weeks. The primary outcome was the proportion of patients achieving an American College of Rheumatology (ACR) 20% (ACR20) response at 48 weeks, analysed by intention to treat with multiple imputation for missing ACR components. Cost-effectiveness was also assessed. This trial is registered with ClinicalTrials.gov, number NCT01106079, and the ISCRCTN registry, number ISCRCTN30147736.Between May 28, 2008, and March 21, 2012, 206 eligible patients were enrolled and randomly assigned to receive tight control (n=101) or standard care (n=105). In the intention-to-treat patient population, the odds of achieving an ACR20 response at 48 weeks were higher in the tight control group than in the standard care group (odds ratio 1·91, 95% CI 1·03–3·55; p=0·0392). Serious adverse events were reported by 20 (10%) patients (25 events in 14 [14%] patients in the tight control group and eight events in six [6%] patients in the standard care group) during the course of the study. No unexpected serious adverse events or deaths occurred.Tight control of psoriatic arthritis disease activity through a treat-to-target approach significantly improves joint outcomes for newly diagnosed patients, with no unexpected serious adverse events reported.Arthritis Research UK and Pfizer.

Using Multiple Daily Pain Ratings to Improve Reliability and Assay Sensitivity: How Many Is Enough?

The Initiative for Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) has reported diminished assay sensitivity in pain treatment trials and recommended investigation of the causes. Specific recommendations included examination of outcome measure reliability and lengthening the baseline measurement period to allow more measurements to be collected. This secondary data analysis evaluated the minimum number of daily pain intensity ratings required to obtain a reliability of at least .90 and whether a composite of this smaller number of ratings was interchangeable with the composite of all ratings. Veterans Affairs medical center patients made 14 daily calls to an automated telephone system to report their average daily pain intensity rating. A single daily rating produced less than adequate reliability (intraclass correlation coefficient = .65), but a composite of the average of 5 ratings resulted in reliability above .90. A Bland-Altman analysis revealed that the differences between a 5-day composite and the composite of all ratings were small (mean .09 points, standard deviation = .45; 95% confidence interval = −.05 to .23) and below the threshold for a clinically meaningful difference, indicating that the 2 measurements are interchangeable. Our results support the IMMPACT recommendations for improving assay sensitivity by collecting a multiple-day baseline of pain intensity ratings. PerspectiveThis study examined the minimum number of pain ratings required to achieve reliability of .90 and examined whether this smaller subset of ratings could be used interchangeably with a composite of all available ratings. Attention to measure reliability could enhance the assay sensitivity, power, and statistical precision of pain treatment trials.

A Study of Multiple Behavioral Addictions in a Substance Abuse Sample

Behavioral addictions (BAs) are underrecognized, even in addiction programs. We assessed BAs in a substance abuse sample (n = 51; data collection 2011–2012). A self-report Behavioral Addictions Screen, assessing eight BAs, was administered using an automated telephone system. Most endorsed at least one BA, with the most common shopping/spending; eating; work; computer/internet; and sex/pornography. Lowest were gambling, self-harm, and exercise. Some BAs were correlated with others. Gender, ethnicity, age, and positive depression and posttraumatic stress disorder screens were associated with specific BAs. Future research could address interpretation of “addiction,” comparison to diagnostic interviews, relationship to substance use disorders, and larger samples.

Association between Length of Exclusive Breastfeeding and Subsequent Breastfeeding Continuation

Although breastfeeding initiation rates have improved, later prevalence is very low in the United Kingdom, and Northeast England is the region with the lowest rates. This study aimed to investigate novel in addition to well-established risk factors for cessation of breastfeeding among women in this region. Participants were 870 women considering breastfeeding prior to birth who were enrolled in the postnatal ward North East Cot trial at a tertiary hospital in Northeast England from 2008 to 2010. They provided weekly data on feeding and sleeping practices for 26 weeks postpartum using an automated telephone system with reminder postcards and contact by telephone, letter, or email if necessary. Cox proportional hazards regression was used to investigate factors associated with terminating any and exclusive breastfeeding in this period. Ninety-four percent of women started any breastfeeding and 66% initiated exclusive breastfeeding. By 26 weeks postpartum, 47% were still breastfeeding, but < 1% were breastfeeding exclusively. Multivariate analysis showed that women who exclusively breastfed for at least 4 weeks breastfed for significantly longer after supplementation started (P < .001). Bed-sharing at home during the first 13 weeks was a significant predictor of both any and exclusive breastfeeding, as well as any breastfeeding after supplementation (P < .001). We also confirmed some recognized socio-demographic predictors of breastfeeding cessation in this location. We found that exclusive breastfeeding for at least 4 weeks was significantly associated with longer breastfeeding continuation after supplementation, and bed-sharing at home was associated with longer breastfeeding regardless of the definition used.