Psychometric Evaluation of the Diary for Irritable Bowel Syndrome Symptoms-Constipation in a Prospective Observational Study.

OBJECTIVES: To evaluate the psychometric properties of the Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C), which was developed to support primary and secondary endpoints in irritable bowel syndrome (IBS) with predominant constipation (IBS-C) clinical trials. METHODS: Observational data were collected from 108 adults with IBS-C using a smartphone-type device for 17 days. DIBSS-C data regarding bowel movements (BMs) were collected for each event (along with the Bristol Stool Form Scale); abdominal symptoms were rated each evening. Global status items and the Gastrointestinal Symptom Rating Scale-IBS were completed on day 10 and day 17 and the IBS-Symptom Severity Scale on day 17. Item-level performance, internal consistency reliability, test-retest reliability, and construct validity were evaluated. RESULTS: The Abdominal Symptoms Domain score demonstrated high internal consistency reliability (Cronbach's alpha week 1 = 0.98; week 2 = 0.96) and test-retest reliability (intraclass correlation coefficient [ICC] = 0.93). Test-retest reliability was stronger for abdominal symptoms (ICC = 0.91-0.94) than for the frequency-based BM-related outcomes (ICC = 0.54-0.66). Key construct validity hypotheses were supported by moderate to strong correlations with the corresponding Gastrointestinal Symptom Rating Scale-IBS, IBS-Symptom Severity Scale, and Bristol Stool Form Scale items. All known-groups comparisons were statistically significant for the abdominal symptom items and domain score; evidence for known-groups validity of BM-related outcomes was supportive when based on constipation severity. CONCLUSIONS: The results of this study provided key psychometric evidence for the DIBSS-C, ultimately contributing to its qualification by the US Food and Drug Administration for use in IBS-C clinical trials.

Patient-reported outcomes in the GARNET trial in patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer treated with dostarlimab.

OBJECTIVE: There is an increase in patient-reported outcome assessments to gain information on new drug candidates from the patient's perspective. A data gap remains in patient-reported outcome measurements for anti-programmed death 1 (anti-PD-1) therapies in endometrial cancer. We present patient-reported outcome measures collected from patients with mismatch repair-deficient/microsatellite instability-high advanced or recurrent endometrial cancer treated with dostarlimab, an anti-PD-1 monoclonal antibody, in an expansion cohort of the GARNET trial. METHODS: GARNET (NCT02715284) is a phase I single-arm study of dostarlimab monotherapy in multiple tumor types. Patients with advanced or recurrent mismatch repair-deficient/microsatellite instability-high endometrial cancer were treated with 500 mg of intravenous dostarlimab once every 3 weeks for four cycles, then 1000 mg of intravenous dostarlimab every 6 weeks. Patient-reported outcome assessments were an exploratory endpoint, measured using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30). RESULTS: At data cut-off, 88 patients with mismatch repair-deficient endometrial cancer were included in the analysis. Patient-reported outcome assessment completion was >95.5% throughout cycle 7 of the trial, with no individual domain completion <90.9%. Quality of life, emotional functioning, and social functioning showed improvement compared with baseline. All symptom scores showed either improvement or stability from baseline through cycle 7. Categorical change in response across all symptom scales and single-item response scores showed stability or improvement for most patients. For patients who saw a worsening of their categorical change in response, ≤7.4% experienced a 2-category worsening and ≤2.5% experienced a 3-category worsening. CONCLUSIONS: Most patients remained stable or had improved quality of life while receiving dostarlimab for the treatment of recurrent or advanced mismatch repair-deficient endometrial cancer. TRIAL REGISTRATION NUMBER: NCT02715284.

Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.

INTRODUCTION: Linaclotide improves abdominal pain and constipation in patients with constipation-predominant irritable bowel syndrome (IBS-C). Patients report additional bothersome abdominal symptoms of bloating and discomfort. The intention of this study was to evaluate linaclotide's efficacy in relieving IBS-C-related abdominal symptoms (bloating, discomfort, and pain) using a novel multi-item Abdominal Score (AS). METHODS: Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 µg or placebo daily for 12 weeks. The AS, derived from the Diary for IBS Symptoms-Constipation, is the average of abdominal bloating, discomfort, and pain at their worst (0 = none, 10 = worst possible). The primary end point was overall change from baseline (CFB) in AS. Secondary end points included CFB in 12-week AS evaluated using cumulative distribution function and 6-week/12-week AS responder (AS improvement ≥2 points for ≥6-week/12-week). RESULTS: Overall, 614 patients (mean age 46.7 years; 81% female) were randomized. All prespecified end points showed significant benefit of linaclotide vs placebo. The mean overall CFB AS reduction for linaclotide was -1.9 vs -1.2 for placebo (P < 0.0001); the 6-week/12-week AS responder rate was 40.5% for linaclotide vs 23.4% for placebo (odds ratio = 2.2 [95% confidence interval, 1.55-3.12; P < 0.0001]). Diarrhea was the most common treatment-emergent adverse event (linaclotide = 4.6%, placebo = 1.6%). DISCUSSION: Linaclotide significantly reduced multiple abdominal symptoms important to patients with IBS-C (bloating, discomfort, and pain) compared with placebo, as measured by a novel multi-item AS. The AS, derived from the Diary for IBS Symptoms-Constipation, should be considered for use in future IBS-C clinical studies to measure clinically meaningful improvements beyond traditional end points.

Psychometric Analysis of the Abdominal Score From the Diary for Irritable Bowel Syndrome Symptoms-Constipation Using Phase IIb Clinical Trial Data.

OBJECTIVES: The Diary for Irritable Bowel Syndrome Symptoms-Constipation (DIBSS-C) has been developed to assess the core signs and symptoms of irritable bowel syndrome with constipation (IBS-C). This article presents the psychometric evaluation of the DIBSS-C abdominal score. METHODS: Data for these analyses are from a multicenter phase IIb study in IBS-C patients (NCT02559206). Subjects completed a number of assessments via handheld electronic diary throughout the study. The analyses used the intent-to-treat population and were blinded to randomized treatment group. The analyses evaluated the reliability, validity, and responsiveness of the DIBSS-C abdominal score; identified an appropriate scoring algorithm; and determined thresholds for interpreting clinically meaningful changes at the individual level. RESULTS: The correlations between the DIBSS-C abdominal symptom items (ie, abdominal pain, discomfort, and bloating) were strong (>0.75). Cronbach's alpha for the abdominal symptom severity items was very strong (.94), indicating that the 3 abdominal symptom items produce a reliable score. The intraclass correlation coefficient for the abdominal score was 0.82, exceeding the threshold of 0.70 and indicating good test-retest reliability. Guyatt's responsiveness statistic values all exceeded the threshold for a large effect of 0.80, so the DIBSS-C abdominal score can be considered highly responsive to change. Triangulation across 3 sets of anchor-based analyses indicated that a threshold of -2.0 points on the abdominal score is an appropriate threshold for identifying meaningful change. CONCLUSIONS: Overall, this study provides evidence that the DIBSS-C abdominal score is valid, reliable, responsive to change, and interpretable for assessing treatment benefit in patients with IBS-C.

Perspectives of patients with advanced or metastatic non-small cell lung cancer on symptoms, impacts on daily activities, and thresholds for meaningful change: a qualitative research study.

Introduction: Advanced or metastatic non-small cell lung cancer (NSCLC) is associated with significant symptom burden. It is important to understand the impact of these disease-and treatment-related symptoms on patients' daily lives and explore from a patient perspective what constitutes a meaningful change in NSCLC symptoms. Methods: Patient experience of advanced or metastatic NSCLC was explored in this prospective, non-interventional qualitative research study recruiting patients from the United States (US). Interviews were conducted to explore the most important symptoms, daily life impacts, and patients' perspectives of what constitutes meaningful change when considering their current symptoms versus 6-12 months prior, based on the Patient Global Impression of Severity (PGI-S) and Patient Global Impression of Change (PGI-C) items. Results: Between February and April 2022, 19 US-based patients with Stage IV NSCLC were recruited; 95% were female, 63% were White, 79% had been diagnosed >1 year prior, and 63% were receiving targeted therapy. Over half the patients indicated their most important symptoms were fatigue, shortness of breath, and cough. Patient differentiation between whether symptoms were disease- or treatment-related lacked concordance, and often patients were unable to distinguish the two. The most frequently mentioned impacts of these symptoms on patients' daily lives were difficulty walking, sleep disturbance, anxiety/depression, impact on relationships, and difficulty doing daily tasks. Most patients considered a one-point change on the PGI-S or PGI-C to be meaningful based on rating their symptom severity at the time of the interview compared with 6-12 months before the interview. Conclusion: Based on their own symptom experience, patients with advanced or metastatic NSCLC indicated a one-point threshold for meaningful change, whether improvement or worsening. This suggests a one-point change on the PGI-S or PGI-C may be a potential anchor for patient-reported outcome (PRO) endpoints used in clinical trials. It is important to use PRO instruments that capture the symptoms and impacts identified as most important to patients. These findings highlight the importance of using qualitative methods to assess disease-related symptoms, treatment-related side effects, and the impacts on daily life for patients with advanced or metastatic NSCLC, underscoring how qualitative assessments can complement quantitative PRO instruments for evaluating clinical trials.

The minimally important difference of the Asthma Control Test.

BACKGROUND: The Asthma Control Test (ACT) has been well validated, but a minimally important difference (MID) has not been established. OBJECTIVE: We sought to identify an MID for the ACT. METHODS: Data come from 4 independent samples of adult asthmatic patients. Distributional methods for determining the MID included 0.5 SD, 1 SEM, and 2 SEM. Anchor-based methods assessed the relationship of differences in ACT scores to (1) self-reported asthma severity, (2) asthma episode frequency in the past 4 weeks, (3) physician ratings of asthma control, (4) physician recommendation of a change in therapy, (5) FEV(1), (6) the risk over the next 12 months of excess short-acting beta-agonist use and exacerbations, and (7) patient-defined changes in asthma course over 3 months. RESULTS: Four thousand one hundred eighteen patients completed the ACT. The 0.5 SD criterion for MID ranged from 2.03 to 2.45 points (mean, 2.2 points). The 1 SEM criterion ranged from 1.77 to 2.05 points (mean, 1.88 points), and the 2 SEM criterion ranged from 3.55 to 4.10 points (mean, 3.75 points). Differences in mean ACT scores across patient groups differing on criterion measures ranged from 1.06 to 5.28 points (mean, 3.1 points). Predictive analyses showed that a difference of 3 points on the ACT was associated with a subsequent 76% increased risk (95% CI, 73% to 79%) of excess short-acting beta-agonist use and a 33% increased risk (95% CI, 31% to 35%) of exacerbations. CONCLUSION: The data support an MID for the ACT of 3 points.

Test for respiratory and asthma control in kids (TRACK): a caregiver-completed questionnaire for preschool-aged children.

BACKGROUND: A validated questionnaire is needed to monitor respiratory control in preschool-aged children. OBJECTIVE: We sought to develop and validate a caregiver-completed questionnaire that measures respiratory control in young children. METHODS: A 33-item questionnaire that included asthma impairment and risk items was administered to 486 caregivers of children aged younger than 5 years with a current, recent, or past history of respiratory symptoms. Stepwise regression was used to select a subset of items with the greatest discriminant validity in relation to guidelines-defined asthma control in a random two-thirds development sample. Reliability, validity, and ability to screen for respiratory control problems were tested in development and validation samples (remaining one-third sample). RESULTS: The content of the 5 items selected, the Test for Respiratory and Asthma Control in Kids (TRACK), included frequency of respiratory symptoms (wheeze, cough, shortness of breath), activity limitation, and nighttime awakenings in the past 4 weeks; rescue medication use in the past 3 months; and oral corticosteroid use in the previous year. Reliability was greater than 0.70 in both samples. ANOVA showed that mean scores differed significantly (P < .001) in the expected direction across both samples for 3 levels of guidelines-based respiratory control, physician-recommended change in therapy, and symptom status. In the development and validation samples, screening analyses revealed areas under the receiver operating characteristic curve of 0.88 and 0.82, respectively; control status was correctly classified in 81% and 78% of cases. CONCLUSION: TRACK is a valid, easy-to-administer, caregiver-completed questionnaire of respiratory control in preschool-aged children with symptoms consistent with asthma.

Evaluation and Validation of the Modified Reflux Symptom Questionnaire-Electronic Diary in Patients With Persistent Gastroesophageal Reflux Disease.

OBJECTIVES: This study aimed to examine the validity of the modified Reflux Symptom Questionnaire-electronic Diary (mRESQ-eD) through patient input and psychometric testing of the questionnaire to support use in clinical trials in patients with persistent gastroesophageal reflux disease (GERD) and in accordance with Food and Drug Administration guidance on patient-reported outcome instruments. METHODS: Cognitive interviews were conducted with patients (n = 30) to evaluate the interpretability and content validity of draft mRESQ-eD items. Patient data from a phase 2b clinical study (ClinicalTrials.gov identifier: NCT02637557) on persistent GERD served to aid in the construction of weekly scores for heartburn severity, regurgitation severity, and total GERD severity. These scores' psychometric properties were also evaluated. RESULTS: Minor modifications were made to the draft mRESQ-eD based on patient feedback to improve interpretability and clarity of the instrument. Psychometric analysis suggested that an 8-item version of the mRESQ-eD was best suited to the clinical data. The internal consistency was found to be high (Coefficient ω = 0.95). Retest reliability and convergent validity were strong for a heartburn weekly severity score, regurgitation weekly severity score, and total GERD severity score. DISCUSSION: The final 8-item mRESQ-eD is a reliable and valid instrument with good psychometric properties for use in clinical trials in patients with persistent GERD. The mRESQ-eD may be considered for inclusion in clinical trials for persistent GERD and potentially positioned, in consultation with Food and Drug Administration, as endpoints to characterize treatment benefit.

Characterizing the burden of premature ejaculation from a patient and partner perspective: a multi-country qualitative analysis.

BACKGROUND: Premature ejaculation (PE) is a common sexual dysfunction among men which affects men and their partners. Little qualitative data are available to characterize the impact of PE on men and their partners about ejaculatory control, sexual satisfaction, emotional distress and relationships. The objective of this study was to assess the impact of PE from the perspective of men with PE and the female partners of men with PE on their sexual experience, distress and relationships. METHODS: Qualitative data were collected through 14 focus groups in the US and through one-on-one interviews in the US, UK, Italy, France, Germany, and Poland. Study participants included heterosexual men with PE and female partners of males with PE. All participants were asked about how PE affects their daily life, including emotional impacts. One-on-one interviews also included obtaining feedback on the male and female versions of 4-single item measures of PE focusing on ejaculatory control, satisfaction with intercourse, interpersonal distress, and relationship difficulty. RESULTS: Participants included 172 males with PE and 67 female partners of men with PE. Lack of control over ejaculation and dissatisfaction with intercourse emerged as central themes of PE. Lack of ejaculatory control resulted in greater dissatisfaction and greater emotional distress, including feelings of inadequacy, disappointment, and anxiety. Continued PE ultimately leads to greater problems with partners and often disrupts partner relationships. Participants indicated that PE was keeping them from attaining complete intimacy in their relationships even when their partners were generally satisfied with sexual intercourse. Impacts of PE on sexual satisfaction, emotional distress and partner relationships were consistent across countries. Feedback on the single-item PE measures confirmed relevance of the item content and further confirmed major themes identified from the qualitative data. CONCLUSION: This qualitative study provides valuable insights on the substantial psychosocial burden of PE in the US and the Europe. Lack of control over ejaculation resulted in dissatisfaction with intercourse and increased emotional distress, and wide-ranging impact for both men with PE and their partners of men with PE. Data collected in this study may help inform the content of new patient reported measures for use in PE research.

Exploring the Diabetic Gastroparesis Patient Experience: Patient Exit Interviews.

INTRODUCTION: To improve understanding of the diabetic gastroparesis (DGP) patient experience and inform the patient-reported outcome measurement strategy for future trials in DGP, qualitative interviews were conducted with participants in a phase 2 clinical trial of a novel DGP treatment. METHODS: Trial participants were invited to participate in interviews at both the pretreatment visit (PTV) and the end-of-treatment visit (EOTV). The interviews were conducted by experienced qualitative researchers and followed a semistructured interview guide. The PTV interviews focused on patients' DGP symptoms and the impact of DGP on their lives, and the EOTV interviews focused on any symptom changes patients experienced during the trial. RESULTS: Of 90 enrolled trial participants, 78 (86.7%) opted to participate in the interview study. Bloating, stomach fullness, upper abdominal pain, vomiting, constipation, and heartburn or reflux were each reported spontaneously by a majority of the 73 PTV interview participants with evaluable data. These patients commonly reported bloating (n = 20), upper abdominal pain (n = 12), and nausea (n = 11) as their most bothersome DGP symptom. Of 51 EOTV interview participants, 44 (86.3%) reported improvement in at least one DGP symptom either spontaneously or when asked about specific symptoms reported during their PTV interview. CONCLUSION: Bloating, abdominal pain, nausea, constipation, stomach fullness, vomiting, and heartburn were frequently reported by patients as the most bothersome and important-to-treat symptoms. These results support the assessment of these symptoms in future DGP clinical trials, whether for symptom improvement or worsening. FUNDING: Ironwood Pharmaceuticals. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02289846.

Literature review to characterize the empirical basis for response scale selection in pediatric populations.

BACKGROUND: Despite the importance of response option selection for patient-reported outcome measures, there seems to be little empirical evidence for the selected scale type. This article provides an overview of the published research on response scale types and empirical support within pediatric populations. METHODS: A comprehensive review of the scientific literature was conducted to identify response scale option types appropriate for use in pediatric populations and to review and summarize the available empirical evidence for each scale type. RESULTS: Eleven review/consensus guideline/expert opinion articles and 20 empirical articles that provided guidance or evidence regarding pediatric response scale selection were identified. There was general consensus that 5-point verbal rating scales, including Likert scales, were appropriate for children aged 7 or 8 and older, while graphical or faces scales are often used in pediatric studies with children of younger ages. CONCLUSION: In general, the verbal rating scale, numeric rating scale, visual analogue scale, and graphical scales have each demonstrated to be reliable and valid response option formats in specific contexts among pediatric populations; however, their appropriateness is dependent upon sample age. When selecting response scales, it is important to consider target population and context of use during the development of patient-reported outcome measures, especially with respect to tense, recall period, attribution, number of options, etc. In addition to age, cognitive development is an important aspect to consider for optimizing pediatric self-reported measures. More research is needed to determine clinically relevant changes and differences within pediatric research, which includes different response scale options.

Response scale selection in adult pain measures: results from a literature review.

BACKGROUND: The purpose of this literature review was to examine the existing patient-reported outcome measurement literature to understand the empirical evidence supporting response scale selection in pain measurement for the adult population. METHODS: The search strategy involved a comprehensive, structured, literature review with multiple search objectives and search terms. RESULTS: The searched yielded 6918 abstracts which were reviewed against study criteria for eligibility across the adult pain objective. The review included 42 review articles, consensus guidelines, expert opinion pieces, and primary research articles providing insights into optimal response scale selection for pain assessment in the adult population. Based on the extensive and varied literature on pain assessments, the adult pain studies typically use simple response scales with single-item measures of pain-a numeric rating scale, visual analog scale, or verbal rating scale. Across 42 review articles, consensus guidelines, expert opinion pieces, and primary research articles, the NRS response scale was most often recommended in these guidance documents. When reviewing the empirical basis for these recommendations, we found that the NRS had slightly superior measurement properties (e.g., reliability, validity, responsiveness) across a wide variety of contexts of use as compared to other response scales. CONCLUSIONS: Both empirical studies and review articles provide evidence that the 11-point NRS is likely the optimal response scale to evaluate pain among adult patients without cognitive impairment.

Patient-reported Symptoms of Tenosynovial Giant Cell Tumors.

PURPOSE: Tenosynovial giant cell tumor (TGCT), a rare locally aggressive neoplasm of the synovium of joints and tendon sheaths, is associated with joint destruction, inflammation, pain, and swelling, in part due to colony-stimulating factor 1 receptor-bearing macrophages recruited to the tumor by genetic elevation of colony-stimulating factor 1 activity. The most common treatment is surgery, although promising pharmacologic treatments are in development. Patient-reported outcome (PRO) instruments are critical end points in demonstrating the clinical relevance of standard oncologic outcome measures and the overall impact of novel pharmacologic therapies in nonmalignant neoplastic conditions such as TGCT. The content validity of PROs relevant to patients with TGCT has not been formally investigated, and instruments to evaluate such outcomes do not exist for this condition. METHODS: PRO instruments of potential relevance were evaluated by using a literature review and by clinical and PRO experts. Patients with TGCT were recruited through clinical sites and the Internet for participation in qualitative research interviews to identify predominant symptoms and to test the relevance and content validity of several PRO measures. Select PRO measures were included in a Phase I clinical trial, and preliminary results of the PRO end points are reported descriptively. FINDINGS: Of the 22 subjects who participated in qualitative interviews, 73% were female, and their mean age was 42.5 years (range, 27-56 years). The TGCTs (19 diffuse and 3 localized) were located in the knee (n = 15), hip (n = 3), ankle (n = 2), elbow (n = 1), and forearm (n = 1). The most common symptoms cited were pain (82%), swelling (86%), stiffness (73%), reduced range of motion (64%), and joint instability (64%), which were consistent with clinical expert input and with the content of instruments chosen by PRO experts. The worst pain numeric rating scale, Patient Reported Outcomes Measurement Information System physical functioning items, and the Western Ontario and McMaster Universities Osteoarthritis Index, as well as a worst stiffness numeric rating scale developed for TGCT, were confirmed as meaningful measures of TGCT patient symptoms and were well understood in qualitative interviews. Results from the Phase I trial showed trends of improvement in both pain and stiffness over time. IMPLICATIONS: This study is the first to gather information directly from patients with TGCT regarding their symptom experiences. Pain, stiffness, and physical functioning are important treatment outcomes in patients with TGCT. We have identified content-valid PRO measures of these concepts, which are included in an ongoing Phase III TGCT clinical trial with pexidartinib (PLX3397) (NCT02371369).

Patient-based utilities for bipolar disorder-related health states.

BACKGROUND: Bipolar disorder is a psychiatric disorder which impacts patient functioning and well-being. With increasing interest in cost-effectiveness of treatments, it is necessary to provide estimates of patient's perspectives on treatment outcomes. This study estimated health state utilities for hypothetical bipolar-related health states and patient's current health from bipolar I patients. METHODS: Clinicians completed Young Mania Rating Scale, Montgomery-Asberg Depression Rating Scale, and Global Assessment Score. Patients completed structured standard gamble (SG) utility assessment interviews, and the other patient-based measures. Interviews obtained utilities for hypothetical bipolar-related health states describing symptom severity, functioning and well-being, and treatment-related side effects. RESULTS: Ninety-six patients were recruited from psychiatry outpatient practices. Mean utilities for inpatient states ranged from 0.12 to 0.33; outpatient mania states ranged from 0.29 to 0.64; outpatient stable states ranged from 0.53 to 0.85. Mean utility for current health was 0.80 (S.D.=0.22). Patients preferred monotherapy compared with combination therapy health states. Ordinary least squares regression indicated weight gain was associated with a 0.066 decrease in health state utilities (P=0.013). LIMITATIONS: Study sample consisted of selected stable and educated patients and small sample sizes may limit generalizability for some utilities. CONCLUSIONS: Bipolar disorder patients are capable of participating in utility assessment and providing ratings for hypothetical health states associated with different mood stabilizer treatments.

Fitting fitness into women's lives: effects of a gender-tailored physical activity intervention.

Although regular exercise has important health benefits, women's physical activity participation remains low. Addressing the gender- and generation-specific barriers in an intervention may help women become more physically active. Fifty women (mean age = 45 years) participated in a six-session cognitive-behavioral intervention. Baseline, post-intervention, and follow-up data were collected. Total physical activity levels increased from baseline to post-intervention and were maintained at long-term follow-up. This research suggests that participation in a comprehensive, cognitive-behavioral, and empowerment-based physical activity intervention, tailored to address women's distinct constraints and pressures due to sociopsychological experiences, can facilitate increased physical activity among white, middle-aged women.

The patient experience of depression and remission: focus group results.

Few depression measures were developed with the patient perspective. To obtain patient views on depression and early symptom resolution, 4 focus groups (N=31) were conducted. Patients also completed the Quick Inventory of Depressive Symptomology (Self-Report), SF-36, and a rating of the bothersomeness and significance of 12 symptoms of depression. Transcripts were reviewed for major themes. Irritability was a key symptom and it remitted earlier than others. Important to participants were low mood, low energy, lack of motivation, lack of focus/concentration, feelings of guilt, self-critical thoughts, feeling overwhelmed, lack of enjoyment, hypersomnia, restlessness, anger, and irritability. Gender differences emerged; most men reported irritability as one of the first symptoms to remit; for women, motivation level and energy commonly remitted first. Results suggest that new measures of treatment outcome should encompass irritability, anger, and ability to cope with life stressors.