Patients' perspectives on the benefits of feedback on patient-reported outcome measures in a web-based personalized decision report for hip and knee osteoarthritis.

BACKGROUND: Applications of patient-reported outcome measures (PROMs) for individual patient management are expanding with the support of digital tools. Providing PROM-based information to patients can potentially improve care experiences and outcomes through informing and activating patients. This study explored patients' perspectives on the benefits of receiving feedback on PROMs in the context of a web-based personalized decision report to guide care for their hip or knee osteoarthritis. METHODS: This qualitative descriptive interview study was nested in a pragmatic clinical trial of a personalized report, which includes descriptive PROM scores and predicted postoperative PROM scores. Patients completed a semi-structured interview within 6 weeks of an office visit with an orthopaedic surgeon. Only patients who reported receiving the report and reviewing it with the surgeon and/or a health educator were included. Data were iteratively analyzed using a combination of deductive and inductive coding strategies. RESULTS: Twenty-five patients aged 49-82 years (60% female, 72% surgical treatment decision) participated and described three primary benefits of the PROM feedback within the report: 1. Gaining Information About My Health Status, including data teaching new information, confirming what was known, or providing a frame of reference; 2. Fostering Communication Between Patient and Surgeon, encompassing use of the data to set expectations, ask and answer questions, and facilitate shared understanding; and 3. Increasing My Confidence and Trust, relating to the treatment outcomes, treatment decision, and surgeon. CONCLUSIONS: Patients identified actual and hypothetical benefits of receiving feedback on PROM scores in the context of a web-based decision report, including advantages for those who had already made a treatment decision before seeing the surgeon. Findings provide insight into patients' perspectives on how digital PROM data can promote patient-centered care. Results should be considered in the context of the homogeneous sample and complex trial. While participants perceived value in this personalized report, questions remain regarding best practices in patient-facing data presentation and engagement. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03102580. Registered on 5 April 2017.

Motivational interviewing intervention for increasing physical activity and improving dietary behaviors: The Lupus Intervention Fatigue Trial protocol.

The Lupus Intervention Fatigue Trial (LIFT) is a prospective, randomized controlled trial to assess the effectiveness of a six-month motivational interviewing intervention program versus an educational control to reduce fatigue in persons with systematic lupus erythematosus (SLE). Participants are randomized using a stratified, 1:1 allocation design to the LIFT intervention or control arm. We plan to enroll 236 participants to achieve the target of 200 persons with six-month follow-up for the primary endpoint. Specific aims of this study are to evaluate the impact of the LIFT intervention on 1) self-reported measures of fatigue and 2) impact on accelerometer-measured physical activity. The primary study outcome is six-month change in fatigue from baseline, assessed by the Fatigue Severity Score (FSS). Additional outcomes include objective measures of physical activity, including non-sedentary behavior and moderate-to-vigorous activity (secondary outcome), and adherence to the LIFT dietary intervention, as assessed by nutrient density (diet quality) and recommended food groups/eating patterns (exploratory outcome) in persons with SLE. Intervention effectiveness will be assessed using an intention-to-treat two-arm comparison of six-month change in FSS, with one interim monitoring analysis. A two-sample independent group t-test will compare the six-month changes in FSS between the study arms. Intervention effect durability will be assessed 12-months after baseline (6 months after completion of the intervention). Enrollment began in June 2019 and is expected to end in June 2023. This study will inform future intervention strategies that promote physical activity and improved diet quality to reduce fatigue in persons with SLE.

Strategies for Effective Implementation of Patient-Reported Outcome Measures in Arthroplasty Practice.

ABSTRACT: Patient-reported outcome measures (PROMs) will be an important component of real-world evidence, but best practices for capture and integration are not yet defined. While digital tools support patients, clinicians, and researchers to collect PROMs, PROM capture in clinical care remains challenging. We synthesized PROM implementation strategies that are successfully used by hundreds of arthroplasty surgeons and early PROM-adopter clinical systems. This information can guide health systems that are preparing to implement PROMs to inform clinical care, drive quality-improvement activities, and support reporting for payer-sponsored incentives. Specific information is included to guide each step in the implementation process, including selecting PROMs, redesigning office procedures, programming of information technology, and informing interpretation and clinical use. While no one solution exists for successful PROM implementation in total hip and total knee replacement, referred to as total joint replacement, these guidelines can inform optimal PROM deployment and the capture of complete PROM data. In addition, we outline future research that is needed to define methods for optimal patient engagement, technology infrastructure, and operational systems to seamlessly integrate PROM collection in clinical care.

Integration of Patient-reported Outcomes in a Total Joint Arthroplasty Program at a High-volume Academic Medical Center.

INTRODUCTION: Despite widely appreciated barriers to successful clinical implementation, the literature regarding how to operationalize electronic health record-integrated patient-reported outcomes (PROs) remains sparse. We offer a detailed summary of the implementation of PROs into the standard of care at a major tertiary academic medical center. METHODS: Collection of four Patient-Reported Outcomes Measurement Information System computer adaptive tests was piloted in a large academic orthopaedic surgery ambulatory clinic starting in October 2016. The Patient-Reported Outcomes Measurement Information System computer adaptive tests (Physical Function, Pain Intensity, Pain Interference, and Ability to Return to Social Roles and Activities) were initially implemented as manual order sets to be administered before surgery through 2 years after surgery. Completion rate over time, mean time to completion for all PRO domains, and the overall distribution of symptom severity were used to evaluate the success of the pilot. A subsequent optimization and redesign of the pilot was conducted using tablets, automation of questionnaire deployment, and improved results review to address obstacles encountered during the pilot phase. RESULTS: Two thousand nine distinct joint arthroplasty patients (mean age = 65) completed at least one set of PRO assessments, with overall completion rates reaching 68% and mean completion time of 3 minutes. Focal points during the implementation process included engagement and training of staff, selection of an appropriate patient population and outcome measures, and user friendly data displays for patients and providers. CONCLUSION: Our pilot program successfully demonstrated that PROs can be administered, scored, and made immediately available within the electronic health record to patients and their providers with minimal disruption of clinical workflows. Although considerable operational and technological challenges remain, we found that the implementation of PROs in clinical care within an ambulatory practice at an academic medical center can be achieved through a constellation of several key factors.

Establishing clinically-relevant terms and severity thresholds for Patient-Reported Outcomes Measurement Information System® (PROMIS®) measures of physical function, cognitive function, and sleep disturbance in people with cancer using standard setting.

PURPOSE: Patient-Reported Outcomes Measurement Information System® (PROMIS®) physical function, cognitive function, and sleep disturbance measures are increasingly used in cancer care. However, there is limited guidance for interpreting the clinical meaning of scores. This study aimed to apply bookmarking, a standard setting methodology, to identify PROMIS score thresholds in the context of cancer care. METHODS: Using item parameters, we constructed vignettes of five items covering the range of possible scores. Focus groups were held with cancer care providers and people with cancer. Terminology for categorizing levels of severity was explored. Participants rank ordered vignettes by severity and then placed bookmarks between vignettes representing different levels of severity. Group discussion was held until consensus on bookmark placement was reached. RESULTS: Clinicians selected "within normal limits," "mild," "moderate," and "severe" to describe levels of severity. Both patients and clinicians were able to apply these labels, but there was not unanimous support for any set of descriptors. Clinicians and patients agreed on all severity thresholds for sleep disturbance. For cognitive and physical function, clinicians and patients agreed on the threshold between "within normal limits" and "mild." However, patients required greater dysfunction than clinicians before applying "moderate" and "severe" labels. CONCLUSIONS: Bookmarking can be applied to develop provisional score interpretation for PROMIS measures. Patients and clinicians were frequently consistent in their bookmark placement. When there was variance, patients required more dysfunction before assigning more severity. Additional research with other cancer samples is needed to evaluate the replicability and generalizability of our findings.

Provider perspectives on the integration of patient-reported outcomes in an electronic health record.

OBJECTIVE: Integrating patient-reported outcomes (PROs) into electronic health records (EHRs) can improve patient-provider communication and delivery of care. However, new system implementation in health-care institutions is often accompanied by a change in clinical workflow and organizational culture. This study examines how well an EHR-integrated PRO system fits clinical workflows and individual needs of different provider groups within 2 clinics. MATERIALS AND METHODS: Northwestern Medicine developed and implemented an EHR-integrated PRO system within the orthopedics and oncology departments. We conducted interviews with 11 providers who had interacted with the system. Through thematic analysis, we synthesized themes regarding provider perspectives on clinical workflow, individual needs, and system features. RESULTS: Our findings show that EHR-integrated PROs facilitate targeted conversation with patients and automated triage for psychosocial care. However, physicians, psychosocial providers, and medical assistants faced different challenges in their use of the PRO system. Barriers mainly stemmed from a lack of actionable data, workflow disruption, technical issues, and a lack of incentives. DISCUSSION: This study sheds light on the ecosystem around EHR-integrated PRO systems (such as user needs and organizational factors). We present recommendations to address challenges facing PRO implementation, such as optimizing data collection and auto-referral processes, improving data visualizations, designing effective educational materials, and prioritizing the primary user group. CONCLUSION: PRO integration into routine care can be beneficial but also require effective technology design and workflow configuration to reach full potential use. This study provides insights into how patient-generated health data can be better integrated into clinical practice and care delivery processes.

Validation of Patient-reported Outcomes Measurement Information System Computer Adaptive Tests in Lumbar Disk Herniation Surgery.

INTRODUCTION: Inadequate validation, floor/ceiling effects, and time constraints limit utilization of standardized patient-reported outcome measures. We aimed to validate Patient-reported Outcomes Measurement Information System (PROMIS) computer adaptive tests (CATs) for patients treated surgically for a lumbar disk herniation. METHODS: PROMIS, CATs, Oswestry Disability Index, and Short Form-12 measures were administered to 78 patients treated with lumbar microdiskectomy for symptomatic disk herniation with radiculopathy. RESULTS: PROMIS CATs demonstrated convergent validity with legacy measures; PROMIS scores were moderately to highly correlated with the Oswestry Disability Index and Short Form-12 physical component scores (r = 0.41 and 0.78, respectively). PROMIS CATs demonstrated similar responsiveness to change compared with legacy measures. On average, the PROMIS CATs were completed in 2.3 minutes compared with 5.7 minutes for legacy measures. DISCUSSION: The PROMIS CATs demonstrate convergent and known groups' validity and are comparable in responsiveness to legacy measures. These results suggest similar utility and improved efficiency of PROMIS CATs compared with legacy measures. LEVELS OF EVIDENCE: Level II.

Development of an eHealth System to Capture and Analyze Patient Sensor and Self-Report Data: Mixed-Methods Assessment of Potential Applications to Improve Cancer Care Delivery.

BACKGROUND: Capturing and Analyzing Sensor and Self-Report Data for Clinicians and Researchers (COMPASS) is an electronic health (eHealth) platform designed to improve cancer care delivery through passive monitoring of patients' health status and delivering customizable reports to clinicians. Based on data from sensors and context-driven administration of patient-reported outcome (PRO) measures, key indices of patients' functional status can be collected between regular clinic visits, supporting clinicians in the delivery of patient care. OBJECTIVE: The first phase of this project aimed to systematically collect input from oncology providers and patients on potential clinical applications for COMPASS to refine the system. METHODS: Ten clinicians representing various oncology specialties and disciplines completed semi-structured interviews designed to solicit clinician input on how COMPASS can best support clinical care delivery. Three cancer patients tested a prototype of COMPASS for 7 days and provided feedback. Interview data were tabulated using thematic content analysis to identify the most clinically relevant objective and PRO domains. RESULTS: Thematic content analysis revealed that clinicians were most interested in monitoring vital statistics, symptoms, and functional status, including the physical activity level (n=9), weight (n=5), fatigue (n=9), sleep quality (n=8), and anxiety (n=7). Patients (2 in active treatment and 1 in remission) reported that they would use such a device, were enthusiastic about their clinicians monitoring their health status, especially the tracking of symptoms, and felt knowing their clinicians were monitoring and reviewing their health status provided valuable reassurance. Patients would, however, like to provide some context to their data. CONCLUSIONS: Clinicians and patients both articulated potential benefits of the COMPASS system in improving cancer care. From a clinician standpoint, data need to be easily interpretable and actionable. The fact that patients and clinicians both see potential value in eHealth systems suggests wider adoption and utilization could prove to be a useful tool for improving care delivery.

Validation of Patient Reported Outcomes Measurement Information System (PROMIS) Computer Adaptive Tests (CATs) in the Surgical Treatment of Lumbar Spinal Stenosis.

STUDY DESIGN: Prospective, cohort study. OBJECTIVE: Demonstrate validity of Patient reported outcomes measurement information system (PROMIS) physical function, pain interference, and pain behavior computer adaptive tests (CATs) in surgically treated lumbar stenosis patients. SUMMARY OF BACKGROUND DATA: There has been increasing attention given to patient reported outcomes associated with spinal interventions. Historical patient outcome measures have inadequate validation, demonstrate floor/ceiling effects, and infrequently used due to time constraints. PROMIS is an adaptive, responsive National Institutes of Health (NIH) assessment tool that measures patient-reported health status. METHODS: Ninety-eight consecutive patients were surgically treated for lumbar spinal stenosis and were assessed using PROMIS CATs, Oswestry disability index (ODI), Zurich Claudication Questionnaire (ZCQ), and Short-Form 12 (SF-12). Prior lumbar surgery, history of scoliosis, cancer, trauma, or infection were excluded. Completion time, preoperative assessment, 6 weeks and 3 months postoperative scores were collected. RESULTS: At baseline, 49%, 79%, and 81% of patients had PROMIS pain behavior (PB), pain interference (PI), and physical function (PF) scores greater than 1 standard deviation (SD) worse than the general population. 50.6% were categorized as severely disabled, crippled, or bed bound by ODI. PROMIS CATs demonstrated convergent validity through moderate to high correlations with legacy measures (r = 0.35-0.73). PROMIS CATs demonstrated known groups validity when stratified by ODI levels of disability. ODI improvements of at least 10 points on average had changes in PROMIS scores in the expected direction (PI = -12.98, PB = -9.74, PF = 7.53). PROMIS CATs demonstrated comparable responsiveness to change when evaluated against legacy measures. PROMIS PB and PI decreased 6.66 and 9.62 and PROMIS PF increased 6.8 points between baseline and 3-months post-op (P < 0.001). Completion time for the PROMIS CATs (2.6 min) compares favorably to ODI, ZCQ, and SF-12 scores (3.1, 3.6, and 3.0 min). CONCLUSION: PROMIS CATs demonstrate convergent validity, known groups validity, and responsiveness for surgically treated patients with lumbar stenosis to detect change over time and are more efficient than legacy instruments. LEVEL OF EVIDENCE: 2.

Validation of Patient-Reported Outcomes Measurement Information System (PROMIS) computerized adaptive tests in cervical spine surgery.

OBJECTIVE The Patient-Reported Outcomes Measurement Information System (PROMIS), which is funded by the National Institutes of Health, is a set of adaptive, responsive assessment tools that measures patient-reported health status. PROMIS measures have not been validated for surgical patients with cervical spine disorders. The objective of this project is to evaluate the validity (e.g., convergent validity, known-groups validity, responsiveness to change) of PROMIS computer adaptive tests (CATs) for pain behavior, pain interference, and physical function in patients undergoing cervical spine surgery. METHODS The legacy outcome measures Neck Disability Index (NDI) and SF-12 were used as comparisons with PROMIS measures. PROMIS CATs, NDI-10, and SF-12 measures were administered prospectively to 59 consecutive tertiary hospital patients who were treated surgically for degenerative cervical spine disorders. A subscore of NDI-5 was calculated from NDI-10 by eliminating the lifting, headaches, pain intensity, reading, and driving sections and multiplying the final score by 4. Assessments were administered preoperatively (baseline) and postoperatively at 6 weeks and 3 months. Patients presenting for revision surgery, tumor, infection, or trauma were excluded. Participants completed the measures in Assessment Center, an online data collection tool accessed by using a secure login and password on a tablet computer. Subgroup analysis was also performed based on a primary diagnosis of either cervical radiculopathy or cervical myelopathy. RESULTS Convergent validity for PROMIS CATs was supported with multiple statistically significant correlations with the existing legacy measures, NDI and SF-12, at baseline. Furthermore, PROMIS CATs demonstrated known-group validity and identified clinically significant improvements in all measures after surgical intervention. In the cervical radiculopathy and myelopathic cohorts, the PROMIS measures demonstrated similar responsiveness to the SF-12 and NDI scores in the patients who self-identified as having postoperative clinical improvement. PROMIS CATs required a mean total of 3.2 minutes for PROMIS pain behavior (mean ± SD 0.9 ± 0.5 minutes), pain interference (1.2 ± 1.9 minutes), and physical function (1.1 ± 1.4 minutes) and compared favorably with 3.4 minutes for NDI and 4.1 minutes for SF-12. CONCLUSIONS This study verifies that PROMIS CATs demonstrate convergent and known-groups validity and comparable responsiveness to change as existing legacy measures. The PROMIS measures required less time for completion than legacy measures. The validity and efficiency of the PROMIS measures in surgical patients with cervical spine disorders suggest an improvement over legacy measures and an opportunity for incorporation into clinical practice.

Longitudinal Validation of the PROMIS Physical Function Item Bank in Upper Extremity Trauma.

OBJECTIVES: To evaluate the reliability, validity, and responsiveness of the Patient-Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Computer Adaptive Test (UE-CAT) and the 8-item Physical Function short form (PF-SF8a) for monitoring outcomes after musculoskeletal injuries in upper extremity trauma patients. DESIGN: Prospective cohort study. SETTING: Two Level-I trauma centers. PATIENTS: Eligible consecutive patients were approached and 424 consented at time 1 (median 9.7 weeks posttreatment). After 6 months, 132 patients (43% of the 307 eligible) completed follow-up measures. INTERVENTION: Cross-sectional and longitudinal monitoring of upper extremity trauma patients treated with or without surgery. MAIN OUTCOME MEASUREMENTS: Reliability, validity, and responsiveness of the UE-CAT and PF-SF8a. Internal consistency reliability, convergent validity correlations, and discriminant validity (by fracture severity and dominant/nondominant extremity groups) were calculated for PROMIS and non-PROMIS forms. Floor and ceiling effects were also examined at both assessment occasions. Responsiveness was evaluated using random-intercept mixed effects models and effect sizes. RESULTS: PROMIS measures had excellent reliability, correlated well with legacy measures, and were responsive to treatment. CONCLUSIONS: PROMIS measures had good statistical properties. In addition to the known advantages of PROMIS, such as lower patient burden and the ability to assess the broadest range of functioning, our data demonstrated that for patients with upper extremity limitations, a region-specific measure such as the UE-CAT may perform more favorably than an overall/full body physical function measure.

The challenge of measuring intra-individual change in fatigue during cancer treatment.

PURPOSE: To evaluate how well three different patient-reported outcomes (PROs) measure individual change. METHODS: Two hundred and fourteen patients (from two sites) initiating first or new chemotherapy for any stage of breast or gastrointestinal cancer participated. The 13-item FACIT Fatigue scale, a 7-item PROMIS® Fatigue Short Form (PROMIS 7a), and the PROMIS® Fatigue computer adaptive test (CAT) were administered monthly online for 6 months. Reliability of measured change was defined, under a population mixed effects model, as the ratio of estimated systematic variance in rate of change to the estimated total variance of measured individual differences in rate of change. Precision of individual measured change, the standard error of measurement of change, was given by the square root of the rate-of-change sampling variance. Linear and quadratic models were examined up to 3 and up to 6 months. RESULTS: A linear model for measured change showed the following by 6 and 3 months, respectively: PROMIS CAT (0.363 and 0.342); PROMIS SF (0.408 and 0.533); FACIT (0.459 and 0.473). Quadratic models offered no noteworthy improvement over linear models. Both reliability and precision results demonstrate the need to improve the measurement of intra-individual change. CONCLUSIONS: These results illustrate the challenge of reliably measuring individual change in fatigue with a level of confidence required for intervention. Optimizing clinically useful measurement of intra-individual differences over time continues to pose a challenge for PROs.

Development and initial validation of the NCCN/FACT symptom index for advanced kidney cancer.

OBJECTIVES: There is a need for a brief symptom index for advanced kidney cancer that includes perspectives of both patients and clinicians and is consistent with the Food and Drug Administration's guidance for patient-reported outcome measures. This study developed and examined the preliminary reliability and validity of the new National Comprehensive Cancer Network/Functional Assessment of Cancer Therapy (FACT)-Kidney Symptom Index 19. METHODS: Fifty patients with advanced kidney cancer provided open-ended and survey responses ranking their most important symptoms. Responses were reconciled with published clinician reports of the most important symptoms. Ten experienced oncologists rated symptoms as disease- or treatment-related. Patients completed quality-of-life and performance status measures. RESULTS: A 19-item index was produced from symptoms that were rated as most important by patients or clinicians. It includes three subscales: disease-related symptoms (DRS), treatment side effects (TSE), and general function and well-being (FWB). Internal consistency was good for the full instrument (α = 0.83), the DRS subscale (α = 0.76), and the FWB subscale (α = 0.78) but lower for the TSE subscale (α = 0.59). Convergent validity was demonstrated through correlations with the FACT-General. Patients with differing performance status were distinguished by the total score (F2,47 = 17.37; P < .0001), the DRS subscale (F2,47 = 14.22; P < .0001), and the FWB subscale (F2,47 = 13.40; P < .0001) but not the TSE subscale (F2,47 =1.48; P = 0.2380). CONCLUSIONS: The National Comprehensive Cancer Network/FACT-Kidney Symptom Index 19 combines symptoms deemed most important by patients and clinicians. Preliminary evidence suggests that the total score and DRS and FWB subscales are reliable and valid as summary indexes. The TSE subscale may be least relevant given the advent of newer therapies.

Expert conference on cancer pain assessment and classification--the need for international consensus: working proposals on international standards.

An increasing number of cancer patients live longer, and palliative care has become an important part of their treatment. Symptoms are often inadequately assessed and managed. A significant challenge in clinical trials is to control for the variability of the samples being studied. To overcome this problem, classification systems have been developed in order to characterise and stratify patients by grouping them according to major common characteristics. The lack of agreed methods for the assessment and classification of cancer pain has been clearly indicated in clinical trials and in clinical practice and may be one possible explanation for the inadequate treatment of cancer pain. This was the background to an international expert meeting arranged in September 2009 in Milan, Italy. The primary aims were to produce recommendations on how to assess and classify cancer pain and to recommend a strategy for the further development, validation and implementation of an international cancer pain classification and assessment system. The recommendations consisted of two basic working proposals, nine specific working proposals and seven recommendations for the further development of a cancer pain classification system. Examples of specific working proposals were to include pain intensity, pain mechanism, breakthrough pain and psychological distress as the core domains in this classification of cancer pain and to measure pain intensity with a 0-10 numerical rating scale with 'no pain' and 'pain as bad as you can imagine' as anchors. The proposed name for this international standard is Cancer Pain Assessment and Classification System (CPACS).

Adjustment and discussion of cancer: a comparison of breast and prostate cancer survivors.

Supportive conversations may facilitate adjustment among cancer patients early in treatment. However, little is known about how cancer discussion is related to adjustment among long-term survivors of cancer or how gender differences may influence associations between cancer discussion and adjustment. The purpose of this study was to examine possible moderator effects of gender on associations between cancer discussions and adjustment among survivors of breast or prostate cancer. Eighty-eight breast and 88 prostate cancer patients were matched by years post-surgery and stage of cancer and completed measures of cancer discussion frequency, quality of life, and depression. Breast and prostate cancer patients differed on what cancer-related threats were discussed most frequently. In addition, among breast, but not prostate cancer patients, frequent cancer discussion was associated with higher depression and lower quality of life. Frequent discussion of cancer may be an indication of poorer adjustment among breast cancer patients at nearly four years post-surgery. The nature and context of cancer discussions may be important determinants of whether cancer discussions relate to adaptive versus maladaptive outcomes.

Coping and quality of life among women extensively treated for gynecologic cancer.

The current study examined the use of engagement and avoidant coping strategies among advanced-stage gynecologic cancer patients who were facing the long-term stressors of extensive chemotherapy and advanced disease. Patients were compared to a reference group of early-stage patients who had received more limited treatment. Compared to the reference group, extensively-treated women more frequently utilized both engagement and avoidant strategies including active coping, seeking social support, and mental disengagement. Use of engagement coping strategies such as active coping and seeking social support were not significantly related to quality of life or mood. However, avoidant coping strategies, including disengagement and cognitive avoidance, were strongly associated with poorer well-being and more distressed mood. Moreover, relationships between coping and quality of life differed between the extensively-treated patients and patients in the limited treatment reference group. The use of avoidance and seeking instrumental support were associated with poorer outcomes among extensively-treated patients but not among the limited treatment group. Results of the current study suggest that coping patterns and outcomes may be more pronounced among cancer patients contending with severe disease and extensive treatment and that avoidant coping strategies may be particularly detrimental with respect to these patients' mood and quality of life.

Coping strategies in patients with interstitial cystitis: relationships with quality of life and depression.

PURPOSE: Previous research has demonstrated that interstitial cystitis patients experience depressive symptoms and decrements to quality of life. However, to our knowledge the extent to which patients may be able to influence quality of life and depressive symptoms through coping strategies has not been investigated in this population. In a number of other chronic conditions specific coping strategies have been associated with the degree of impairment beyond disease severity. Therefore, the association of coping strategies with depressive symptoms, quality of life and self-reports of pain was assessed in patients with interstitial cystitis. MATERIALS AND METHODS: A total of 64 females with interstitial cystitis were recruited from a urology clinic at a tertiary medical center. Questionnaires assessing depression, quality of life, coping and symptom severity were completed and returned at a clinic appointment. Depression was also measured through a standardized semi-structured interview (Hamilton Rating Scale for Depression). All analyses controlled for age. RESULTS: Patients coping by greater catastrophizing reported greater impairments in various domains, including depressive symptoms, general mental health, social functioning, vitality and pain. Greater venting was associated with greater depressive symptoms and poorer mental health. Seeking instrumental social support was associated with fewer depressive symptoms. CONCLUSIONS: These findings suggest that maladaptive coping strategies are associated with higher levels of depressive symptoms and quality of life decrements in patients with this condition. Psychosocial interventions aimed at increasing adaptive coping may positively impact the female experience with interstitial cystitis.

Depressive symptoms and quality of life in patients with interstitial cystitis.

PURPOSE: Previous research suggests that patients with interstitial cystitis have poorer quality of life and higher levels of depressive symptoms. However, most studies to date have been limited by the lack of standard measures to describe the experience of living with interstitial cystitis. In addition, to our knowledge no study has used a structured interview to assess depressive symptomatology. We investigated the extent of depressive symptoms and impaired quality of life in a sample of female patients with interstitial cystitis compared with healthy controls. Relationships among physician rated symptom severity, quality of life and depressive symptoms were also examined. MATERIALS AND METHODS: At a clinic visit 65 female patients previously diagnosed with interstitial cystitis and 40 age matched, healthy controls completed questionnaires on depressive symptoms (Beck Depression Inventory) and quality of life (Medical Outcomes Study 36-Item Short Form), and a structured interview on depressive symptoms (Hamilton Rating Scale for Depression) with trained interviewers. RESULTS: Patients reported compromised quality of life compared with healthy controls across various domains, including physical functioning, ability to function in one's normal role and vitality. They also had more severe depressive symptoms on the 2 depression measures. In patients, greater interstitial cystitis severity was associated with greater compromise in physical and social functioning, and mental health but not in other quality of life domains or depressive symptoms. CONCLUSIONS: A diagnosis of interstitial cystitis is related to poorer functioning in various life domains. Decrements increase with disease severity.

Diurnal cortisol variations and symptoms in patients with interstitial cystitis.

PURPOSE: Little attention has focused on systemic factors that may allow a state of chronic bladder inflammation to be established and maintained in interstitial cystitis cases. Abnormalities of the hypothalamic-pituitary-adrenal feedback system result in poorer regulation of the inflammatory response and are present in many chronic inflammatory and pain conditions, of which some have high co-morbidity with interstitial cystitis. MATERIALS AND METHODS: A total of 48 patients with interstitial cystitis and 35 healthy, age matched controls collected 24-hour urine samples and 3 days of salivary samples at 7 to 8 a.m., 4 to 5 p.m. and 8 to 9 p.m. for cortisol analysis. In addition, they completed a concurrent symptom questionnaire. Prospective symptom diaries also were completed in the month before sampling. RESULTS: Mean urinary or salivary cortisol did not differ in patients and controls. However, patients with interstitial cystitis and higher morning cortisol had significantly less pain and urgency, while those with higher urinary free cortisol reported less overall symptomatology (p <0.05). Relationships with morning cortisol were also observed when controlling for co-morbid conditions known to be affected by the hypothalamic-pituitary-adrenal axis, such as fibromyalgia, chronic fatigue and rheumatoid arthritis. Patients with morning cortisol less than 12.5 nmol./l. were 12.8 times more likely to report high urinary urgency than those with values above this cutoff. CONCLUSIONS: These findings imply that regulation of the hypothalamic-pituitary-adrenal axis may be associated with interstitial cystitis symptomatology and there may be different diurnal hypothalamic-pituitary-adrenal patterns in patients with interstitial cystitis who do and do not have co-morbid conditions. These findings may have treatment implications for patients with interstitial cystitis who have early morning cortisol deficiencies.