Development and validation of the patient-reported outcome for older people living with HIV/AIDS in China (PROHIV-OLD).

BACKGROUND: The involvement of quality of life as the UNAIDS fourth 90 target to monitor the global HIV response highlighted the development of patient-reported outcome (PRO) measures to help address the holistic needs of people living with HIV/AIDS (PLWHA) beyond viral suppression. This study developed and tested preliminary measurement properties of a new patient-reported outcome (PROHIV-OLD) measure designed specifically to capture influences of HIV on patients aged 50 and older in China. METHODS: Ninety-three older people living with HIV/AIDS (PLWHA) were interviewed to solicit items and two rounds of patient cognitive interviews were conducted to modify the content and wording of the initial items. A validation study was then conducted to refine the initial instrument and evaluate measurement properties. Patients were recruited between February 2021 and November 2021, and followed six months later after the first investigation. Classical test theory (CTT) and item response theory (IRT) were used to select items using the baseline data. The follow-up data were used to evaluate the measurement properties of the final instrument. RESULTS: A total of 600 patients were recruited at the baseline. Of the 485 patients who completed the follow-up investigation, 483 were included in the validation sample. The final scale of PROHIV-OLD contained 25 items describing five dimensions (physical symptoms, mental status, illness perception, family relationship, and treatment). All the PROHIV-OLD dimensions had satisfactory reliability with Cronbach's alpha coefficient, McDonald's ω, and composite reliability of each dimension being all higher than 0.85. Most dimensions met the test-retest reliability standard except for the physical symptoms dimension (ICC = 0.64). Confirmatory factor analysis supported the structural validity of the final scale, and the model fit index satisfied the criterion. The correlations between dimensions of PROHIV-OLD and MOS-HIV met hypotheses in general. Significant differences on scores of the PROHIV-OLD were found between demographic and clinical subgroups, supporting known-groups validity. CONCLUSIONS: The PROHIV-OLD was found to have good feasibility, reliability and validity for evaluating health outcome of Chinese older PLWHA. Other measurement properties such as responsiveness and interpretability will be further examined.

Developmental Risk for Infants with Cleft Lip with or Without Cleft Palate Based on Caregiver-Proxy Reports.

OBJECTIVES: (1) Assess caregiver-reported development in infants born with cleft lip ± alveolus (CL ± A) and cleft lip and palate (CLP); (2) determine factors associated with increased developmental risk; and (3) determine consistency of developmental risk before and after surgery for cleft lip. DESIGN: Prospective, longitudinal assessment of development. Time (T) 1, prior to lip closure; T2, 2 months post lip closure. SETTING: Three US craniofacial teams and online parent support groups. PARTICIPANTS: 123 total caregivers (96% mothers); 100 at T1, 92 at T2, and 69 at both T1 and T2. MEASURE: Ages and Stages Questionnaire-3 (ASQ-3): Communication, Gross Motor, Fine Motor, Problem Solving, Personal Social Domains. RESULTS: At T1 47%; at T2 42% passed all 5 Domains; 36% of infants pass all 5 Domains at both T1 and T2. Infants with CLP were at greatest risk on Communication [B = 1.449 (CI = .149-20.079), p = .038; Odds Ratio (OR) = 4.3 (CI = .923-19.650)] and Gross Motor Domains [B = 1.753 (CI = .316-20.605), p = .034; OR = 5.8 (CI = 1.162-28.671)]. Male infants were at greatest risk on Fine Motor [B = 1.542 (CI = .495-20.005), p = .009; OR = 4.7 (CI = 1.278-17.101)] and Problem Solving Domains [B = 1.200 (CI = .118-19.708), p = .044; OR = 3.3 (CI = .896-12.285)]. CONCLUSIONS: Based on caregiver report, infants with CL ± A and CLP meet referral criteria at a high rate. Infants with CLP and male infants were at greatest risk. Regular developmental screening is recommended.

Exploration of Caregiver Interrater Agreement and Test-Retest Reliability on the Infant Cleft Observer Outcomes (iCOO).

Caregiver and observer-reported measures are frequently used as outcomes for research on infants and young children who are unable to report on their own health. Our team developed the Infant with Clefts Observation Outcomes Instrument (iCOO) for infants with cleft lip with or without cleft palate. This exploratory study compared test-retest and interrater reliabilities to inform whether differences in caregiver perspective might affect the iCOO.This study is a secondary analysis comparing caregiver interrater agreement to test-retest reliability. Twenty-five pairs of caregivers completed the iCOO before surgery, 1 week later for test-retest reliability, 2 days after surgery, and 2 months after surgery. Reliability was assessed using intraclass correlations (ICCs) and t-tests were used to compare ratings between caregivers.Infants had cleft lip (28%) or cleft lip and palate (72%). Primary caregivers were predominantly mothers (92%) and secondary caregivers were predominantly fathers (80%). Test-retest reliability met psychometric standards for most items on the iCOO (81%-86% of items). Caregiver agreement on the iCOO items was lower than test-retest reliability (33%-46% of items met psychometric standards). Caregivers did not systematically differ in whether they rated infants as healthier or less healthy than the other caregiver (5%-16% of items had statistically significant differences).Caregivers used the measure consistently, but had different experiences and perceptions of their infant's health and functioning. Future studies are needed to explore mechanisms for the differences in test-retest and interrater reliability. Whenever possible, the same caregiver should provide ratings of the infant, including on the iCOO.

Infant with Clefts Observation Outcomes Instrument (iCOO): A New Outcome for Infants and Young Children with Orofacial Clefts.

OBJECTIVE: We evaluated the measurement properties for item and domain scores of the Infant with Clefts Observation Outcomes Instrument (iCOO). DESIGN: Cross-sectional (before lip surgery) and longitudinal study (preoperative baseline and 2 days and 2 months after lip surgery). SETTING: Three academic craniofacial centers and national online advertisements. PARTICIPANTS: Primary caregivers with an infant with cleft lip with or without cleft palate (CL ± P) scheduled to undergo primary lip repair. There were 133 primary caregivers at baseline, 115 at 2 days postsurgery, and 112 at 2 months postsurgery. MAIN OUTCOME MEASURE(S): Caregiver observation items (n = 61) and global impression of health and function items (n = 8) across eight health domains. RESULTS: Mean age at surgery was 6.0 months (range 2.7-11.8 months). Five of eight iCOO domains have scale scores, with Cronbach's alphas ranging from 0.67 to 0.87. Except for the Facial Skin and Mouth domain, iCOO scales had acceptable intraclass correlation coefficients (ICCs) ranging from 0.76 to 0.84. The internal consistency of the Global Impression items across all domains was 0.90 and had acceptable ICCs (range 0.76-0.91). Sixteen out of 20 (nonscale) items had acceptable ICCs (range 0.66-0.96). As anticipated, iCOO scores 2 days postoperatively were generally lower than baseline and scores 2 months postsurgery were consistent with baseline or higher. The iCOO took approximately 10 min to complete. CONCLUSIONS: The iCOO meets measurement standards and may be used for assessing the impact of cleft-related treatments in clinical research and care. More research is needed on its use in various treatment contexts.

Caregiver Observations of Infant Well-Being Before and After Cleft Lip Surgery.

OBJECTIVE: To evaluate the sensitivity to change of daily ratings of the comfort (COMF) and behavioral/emotional health (BEH) domains of the Infants with Clefts Observation Outcomes Instrument (iCOO) at 3 time points, and to assess the association of post-surgical interventions on iCOO ratings. DESIGN: The COMF and BEH domains were completed by caregivers before (T0), immediately after (T1), and 2-months after (T2) cleft lip (CL) surgery. Analyses included descriptive statistics, correlations, t-tests, and generalized estimating equations. PARTICIPANTS: Caregivers (N = 140) of infants with CL with/without cleft palate. MAIN OUTCOME MEASURES: The COMF and BEH domain scores of the iCOO: Scale (SCALE), a summary of observable signs; and Global Impression (IMPR), a single item measuring caregivers' overall impression. RESULTS: Daily COMF and BEH SCALE and IMPR scores changed significantly during T1 (P's < 0.001) but not T0 or T2. Day 1 and 7 T0 scores were significantly higher than Day 1 and 7 T1 scores (P's <0.001 to <0.012) but similar at T2 (P's > 0.05). After CL surgery, the combined use of immobilizers and nasal stents and the use of multiple feeding methods with treatment for gastroesophageal reflux were associated with lower daily scores in COMF and BEH SCALE and IMPR (P's: 0.040 to <0.001). CONCLUSIONS: COMF and BEH iCOO scores were sensitive to daily changes in infant well-being following CL surgery. Future studies should further investigate impact of post-surgical treatments on infant well-being.

Detecting response shift in health-related quality of life measurement among patients with hypertension using structural equation modeling.

BACKGROUND: Outcomes derived from longitudinal self-reported health-related quality of life measures can be confounded by response shift. This study was aimed to detect response shift among patients with hypertension attending a community-based disease management program. METHODS: 240 consecutive consulting or follow-up patients with diagnosed hypertension were recruited. The Short Form 36-item Health Survey was self-administered at 12 community health service stations at baseline and four weeks after attending the program. The 4-step structural equation modeling approach assessed response shift. RESULTS: Data from 203 (84.6%) patients were eligible for analyses (mean age 65.9 ± 10.8 years, 46.3% female). The results showed uniform recalibration of social functioning ([Formula: see text](1) = 22.98, P < 0.001), and non-uniform recalibration of role limitations due to physical problems ([Formula: see text](1) = 8.84, P = 0.003), and bodily pain ([Formula: see text](1) = 17.41, P < 0.001). The effects of response shift on social functioning were calculated as "small" (effect-size = 0.35), but changed the observed changes from improvement (effect-size = 0.25) to slight deterioration (effect-size = -0.10). After accounting for the response shift effect, the general physical health of participants was improved (effect-size = 0.37), while deterioration (effect-size = -0.21) in the general mental health was also found. CONCLUSIONS: Recalibration existed among patients with hypertension attending the disease management program. The interventions in the program might act as a catalyst that induced the response shift. We conclude that response shift should be considered in hypertension research with longitudinal health-related quality of life data.

Development of an Outcome Measure of Observable Signs of Health and Well-Being in Infants With Orofacial Clefts.

OBJECTIVE: To develop an outcomes instrument that assesses observations that can be reliably reported by caregivers and can be used to assess health of infants with a cleft lip or cleft lip and cleft palate (CL±P) and impacts of treatments. DESIGN: Cross-sectional, mixed methods study. SETTING: Caregivers and health-care providers were recruited from 3 academic craniofacial centers and national advertisements. Most interviews were conducted by telephone, and surveys were completed online. PARTICIPANTS: Caregivers had a child less than 3 years of age with CL±P and spoke either English or Spanish. Health-care providers were members of a cleft team. Caregivers (n = 492) and health-care professionals (n = 75) participated in at least one component of this study. MAIN OUTCOME MEASURE(S): Caregivers and health-care providers participated in tasks related to instrument development: concept elicitation for items within relevant health domains, prioritization of items, and item review. RESULTS: We identified 295 observations of infant well-being across 9 health areas. Research staff and specialists evaluated items for clarity, specificity to CL±P, and responsiveness to treatment. Caregivers and health-care providers rated the resulting list of 104 observations and developed the final instrument of 65 items. CONCLUSIONS: In this phase of development of the Infant with Clefts Observation Outcomes (iCOO) instrument, items were developed to collect caregiver observations about indicators of children's health and well-being across multiple domains allowing for psychometric testing, sensitivity to changes associated with treatment, and documentation of the effects of treatment.

Implementing patient-reported outcome measures in clinical practice: a companion guide to the ISOQOL user's guide.

PURPOSE: The use of patient-reported outcome (PRO) measures in clinical practice is increasing. Following the creation of a 'User's Guide to Implementing PRO Assessment in Clinical Practice' by the International Society for Quality of Life Research (ISOQOL), volunteers from ISOQOL sought to create a Companion Guide to assist health care providers with the scientific and practical considerations involved in implementing and using PRO measures in clinical care by using information from real-world case studies. This paper summarizes the key issues presented in the Companion Guide. METHODS: Ten respondents, who were members of the ISOQOL's CP-SIG and worked in various clinical areas, participated in a survey or telephone interview. Participants were from Canada (n = 2), Denmark (n = 1), England (n = 2), Holland (n = 1), and the United States (n = 4). RESULTS: Based on the information provided by respondents, a Companion Guide was produced, organized according to the nine questions presented in the User's Guide. An additional section for key take-home messages was also provided. This guide provides examples of issues and considerations related to the implementation of PRO measures in clinical practice. CONCLUSIONS: Respondents provided insight into their experiences and emphasized that PRO initiatives were likely to be more successful if there is purposeful, designed integration into clinical practice, meaningful substantive engagement with all stakeholders and access to necessary organizational resources. The ability to leverage existing technology as well as realistic and stakeholder consensus-driven expectations for planning and timing were also key to the successful implementation of PRO measures.

Parent Observations of the Health Status of Infants With Clefts of the Lip: Results From Qualitative Interviews.

OBJECTIVE: To explore, using semistructured qualitative interviews, parent observations of their infant's health as they relate to having a cleft lip or cleft lip and cleft palate (CL±P) and/or associated treatments. DESIGN: Cross-sectional, qualitative study across 3 sites. SETTING: Parents were recruited from 3 academic craniofacial centers. Most interviews were conducted over the telephone, audio-recorded, and transcribed. PARTICIPANTS: Forty-one parents (31 English-, 10 Spanish-speaking) were interviewed. Parents had a child ages 1 to 35 months diagnosed with CL±P. MAIN OUTCOME MEASURE(S): Twelve domains reflecting infant health and well-being, likely affected by a CL±P and/or associated treatments, were identified from clinical experience and literature review. Study investigators conducted semistructured interviews based on 12 identified domains. After transcripts of the interviews were reviewed, our multidisciplinary team selected illustrative quotes from each domain that reflected consistent observations made by parents. RESULTS: Parents' responses covered all 12 domains. Specifically, parents discussed the domain of feeding most frequently, followed by observations about sleep, development, comfort, breathing, and vocalization. CONCLUSIONS: We found that parents of infants with clefts provided caregiver-centered language useful in describing their daily observations. No additional domains of infant health were noted by parents. We will use these observations and language to develop and validate a parent-reported observation diary that can augment assessments of the impacts of interventions on infants who are receiving care for CL±P.

Development and Content Validation of a Patient-Reported Sexual Risk Measure for Use in Primary Care.

BACKGROUND: Patient-provider sexual risk behavior discussions occur infrequently but may be facilitated by high-quality sexual risk screening tools. OBJECTIVE: To develop the Sexual Risk Behavior Inventory (SRBI), a brief computer-administered patient-reported measure. DESIGN: Qualitative item development/quantitative instrument validation. PARTICIPANTS: We developed SRBI items based on patient interviews (n = 128) at four geographically diverse US primary care clinics. Patients were diverse in gender identity, sex, sexual orientation, age, race/ethnicity, and HIV status. We compared sexual risk behavior identified by the SRBI and the Risk Assessment Battery (RAB) among patients (n = 422). APPROACH: We constructed an item pool based on validated measures of sexual risk, developed an in-depth interview guide based on pool content, and used interviews to elicit new sexual risk concepts. We coded concepts, matched them to item pool content, and developed new content where needed. A provider team evaluated item clinical relevance. We conducted cognitive interviews to assess item comprehensibility. We administered the SRBI and the RAB to patients. KEY RESULTS: Common, clinically relevant concepts in the SRBI included number of sex partners; partner HIV status; partner use of antiretroviral medication (ART)/pre-exposure prophylaxis (PrEP); and recent sex without barrier protection, direction of anal sex, and concern regarding HIV/STI exposure. While 90% reported inconsistent condom use on the RAB, same-day SRBI administration revealed that for over one third, all their partners were on ART/PrEP. CONCLUSION: The SRBI is a brief, skip-patterned, clinically relevant measure that ascertains sexual risk behavior across sex, sexual orientation, gender identity, partner HIV serostatus, and partner treatment status, furnishing providers with context to determine gradations of risk for HIV/STI.

Prioritizing research topics: a comparison of crowdsourcing and patient registry.

PURPOSE: A cornerstone of patient-centered outcome research is direct patient involvement throughout the research process. Identifying and prioritizing research topics is a critical but often overlooked point for involvement, as it guides what research questions are asked. We assess the feasibility of involving individuals with low back pain in identifying and prioritizing research topics using two approaches: an existing patient registry and an online crowdsourcing platform. We compare and contrast the diversity of participants recruited, their responses, and resources involved. METHODS: Eligible participants completed a survey ranking their five highest priority topics from an existing list and supplying additional topics not previously identified. We analyzed their responses using descriptive statistics and content analysis. RESULTS: The patient registry yielded older (mean age 72.4), mostly White (70%), and well-educated (95% high school diploma or higher) participants; crowdsourcing yielded younger (mean age 36.6 years), mostly White (82%), and well-educated (98% high school diploma or higher) participants. The two approaches resulted in similar research priorities by frequency. Both provided open-ended responses that were useful, in that they illuminate additional and nuanced research topics. Overall, both approaches suggest a preference towards topics related to diagnosis and treatment over other topics. CONCLUSION: Using a patient registry and crowdsourcing are both feasible recruitment approaches for engagement. Researchers should consider their approach, community, and resources when choosing their recruitment approach, as each approach has its own strengths and weaknesses. These approaches are likely most appropriate to supplement or to complement in-person and ongoing engagement strategies.

Patient-Reported Outcome Measures in Urethral Reconstruction.

PURPOSE OF REVIEW: Treatment of anterior urethral stricture disease (USD) has shifted from endoscopic approaches to urethroplasty with significantly higher success rates among reconstructive urologists. This academic stance has led to a critical evaluation of "success" and developing disease-specific instruments to assess surgical outcomes focusing on patients' satisfaction rather than the historical goal of avoiding secondary procedures. RECENT FINDINGS: Many disease non-specific and/or non-validated patient-reported outcome measures (PROMs) have been utilized to evaluate the voiding symptoms and sexual of function of patients after urethroplasty in the literature. Urethral Stricture Surgery PROM (USS PROM) is the first validated, disease-specific PROM for anterior USD which has been designed in 2001. Urethral Stricture Symptoms and Impact Measure (USSIM) is a comprehensive PROM and is currently being validated at multiple institutions. This article reviews the tools used to assess success after urethroplasty and elaborates the need to develop a comprehensive USD-specific PROM.

Caregiver-Reported Indicators of Communication and Social Functioning for Young Children Who Are Deaf or Hard of Hearing.

We elicited caregiver-reported observations of children aged 5-10 who were deaf or hard of hearing (DHH) that resulted in two age-specific instruments: Caregiver Report of Behaviors and Events (CROBE-DHH 5-7 and 8-10). These new instruments record observations on communication and social behaviors/events. In Study 1, 36 caregivers provided qualitative data on important content on what they were able to observe for instrument development and in Study 2, 271 provided data for studying cross-sectional measurement properties. Two modules resulted in 11 items for children age 5-7 and 15 items for children 8-10 years. Items showing good 7-day reproducibility (ICC over .70) and fair 4-week reproducibility (ICC over .50) were retained. Children with milder hearing loss received higher (better) scores. Items did not distinguish between those with or without cochlear implants. Analyses suggest that the instruments are best used as individual indicator items. In both age groups, caregivers reported youths missed out on family conversations and spent little time on their own. These content-validated indicators apply to all children with DHH. Further work will evaluate the usefulness of these indicators in evaluating change in communication and social behaviors, and the implications of results for intervention.

Comprehensive Qualitative Assessment of Urethral Stricture Disease: Toward the Development of a Patient Centered Outcome Measure.

PURPOSE: The primary objective of this study was to report what patients considered to be the most important symptoms, functions and impacts of urethral stricture disease. Patient and physician perspectives were correlated. MATERIALS AND METHODS: Patients were involved at each step of patient reported outcome measure development. We performed 1) qualitative semistructured concept elicitation interviews, 2) cognitive interviews, 3) prioritization interviews and 4) item prioritization by patients in regard to bother. A total of 22 reconstructive urologists ranked the items in regard to making treatment decisions. RESULTS: Patient qualitative interviews were done until no new information was gained (16 interviews) to reach concept saturation. A total of 40 items were generated from interview data. Urinary items predominated over sexually related content (34 vs 6). A review of published patient reported outcome measures revealed 10 legacy items that were not derived from the qualitative interviews. Two iterative rounds of cognitive interviews were performed in a separate cohort of 5 and 4 patients, respectively, to assess patient comprehension. Item prioritization was done in a separate cohort of 20 patients. The final instrument for validation included 31 items, of which 27 were new and 4 were legacy items. For the top 15 ranked items there was 53% agreement between patients and physicians. Patients were most worried about inability to urinate and urinary dribbling. CONCLUSIONS: We found multiple patient generated concepts related to urinary and sexual impact, function and symptoms. Patients and clinicians had a low agreement rate regarding item importance.

Preliminary validation of the Claudication Symptom Instrument (CSI).

This article describes the development of the Claudication Symptom Instrument (CSI) and its measurement properties for evaluating the symptom experience of patients diagnosed with intermittent claudication (IC). We conducted semi-structured qualitative interviews with IC patients for item development and cognitive interviews in which patient comprehension of items was tested. We evaluated measurement properties using data collected and analyzed in the context of an observational comparative effectiveness study of IC treatments. Items measuring five symptom important to patients were developed and cognitively tested: Pain, Numbness, Heaviness, Cramping, and Tingling. Item means (higher means worse) ranged from 1.1 (Tingling) to 2.3 (Pain) (range: 0 'none' to 4 'extreme'). Rasch analysis yielded support for an overall score (χ2=26.5, df=20, p=0.15). The total CSI score differed by clinician-rated severity of mild versus moderate ( p<0.05), but not moderate versus severe. Re-administration of the CSI 5-10 days after baseline yielded an intra-class correlation coefficient of 0.86. Changes in CSI total score and VASCUQOL total score between baseline and 6 months post-treatment were correlated at -0.52 ( p<0.05). The CSI preliminarily meets accepted measurement standards for content validity, internal consistency and test-retest reliability, construct validity, and sensitivity for detecting change. Because of its high test-retest reliability, it may also be useful in clinical care with individual patients. It takes approximately 3 minutes to complete.

The Promise and Pitfalls of Using Crowdsourcing in Research Prioritization for Back Pain: Cross-Sectional Surveys.

BACKGROUND: The involvement of patients in research better aligns evidence generation to the gaps that patients themselves face when making decisions about health care. However, obtaining patients' perspectives is challenging. Amazon's Mechanical Turk (MTurk) has gained popularity over the past decade as a crowdsourcing platform to reach large numbers of individuals to perform tasks for a small reward for the respondent, at small cost to the investigator. The appropriateness of such crowdsourcing methods in medical research has yet to be clarified. OBJECTIVE: The goals of this study were to (1) understand how those on MTurk who screen positive for back pain prioritize research topics compared with those who screen negative for back pain, and (2) determine the qualitative differences in open-ended comments between groups. METHODS: We conducted cross-sectional surveys on MTurk to assess participants' back pain and allow them to prioritize research topics. We paid respondents US $0.10 to complete the 24-point Roland Morris Disability Questionnaire (RMDQ) to categorize participants as those "with back pain" and those "without back pain," then offered both those with (RMDQ score ≥7) and those without back pain (RMDQ <7) an opportunity to rank their top 5 (of 18) research topics for an additional US $0.75. We compared demographic information and research priorities between the 2 groups and performed qualitative analyses on free-text commentary that participants provided. RESULTS: We conducted 2 screening waves. We first screened 2189 individuals for back pain over 33 days and invited 480 (21.93%) who screened positive to complete the prioritization, of whom 350 (72.9% of eligible) did. We later screened 664 individuals over 7 days and invited 474 (71.4%) without back pain to complete the prioritization, of whom 397 (83.7% of eligible) did. Those with back pain who prioritized were comparable with those without in terms of age, education, marital status, and employment. The group with back pain had a higher proportion of women (234, 67.2% vs 229, 57.8%, P=.02). The groups' rank lists of research priorities were highly correlated: Spearman correlation coefficient was .88 when considering topics ranked in the top 5. The 2 groups agreed on 4 of the top 5 and 9 of the top 10 research priorities. CONCLUSIONS: Crowdsourcing platforms such as MTurk support efforts to efficiently reach large groups of individuals to obtain input on research activities. In the context of back pain, a prevalent and easily understood condition, the rank list of those with back pain was highly correlated with that of those without back pain. However, subtle differences in the content and quality of free-text comments suggest supplemental efforts may be needed to augment the reach of crowdsourcing in obtaining perspectives from patients, especially from specific populations.

Pain and Urinary Symptoms Should Not be Combined into a Single Score: Psychometric Findings from the MAPP Research Network.

PURPOSE: The purpose of this study was to create symptom indexes, that is scores derived from questionnaires to accurately and efficiently measure symptoms of interstitial cystitis/bladder pain syndrome and chronic prostatitis/chronic pelvic pain syndrome, collectively referred to as urological chronic pelvic pain syndromes. We created these indexes empirically by investigating the structure of symptoms using exploratory factor analysis. MATERIALS AND METHODS: As part of the MAPP (Multi-Disciplinary Approach to the Study of Chronic Pelvic Pain) Research Network 424 participants completed questionnaires, including GUPI (Genitourinary Pain Index), ICSI (Interstitial Cystitis Symptom Index) and ICPI (Interstitial Cystitis Problem Index). Individual items from questionnaires about bladder and pain symptoms were evaluated by principal component and exploratory factor analyses to identify indexes with fewer questions to comprehensively quantify symptom severity. Additional analyses included correlating symptom indexes with symptoms of depression, which is a known comorbidity of patients with pelvic pain. RESULTS AND CONCLUSIONS: Exploratory factor analyses suggested that the 2 factors pain severity and urinary severity provided the best psychometric description of items in GUPI, ICSI and ICPI. These factors were used to create 2 symptom indexes for pain and urinary symptoms. Pain, but not urinary symptoms, was associated with symptoms of depression on multiple regression analysis, suggesting that these symptoms may impact patients with urological chronic pelvic pain syndromes differently (B ± SE for pain severity = 0.24 ± 0.04, 95% CI 0.16-0.32, ß = 0.32, p <0.001). Our results suggest that pain and urinary symptoms should be assessed separately rather than combined into 1 total score. Total scores that combine the separate factors of pain and urinary symptoms into 1 score may be limited for clinical and research purposes.

Content validity of Patient-Reported Outcomes Measurement Information System (PROMIS) items in the context of HIV clinical care.

PURPOSE: To assess content validity and patient and provider prioritization of Patient-Reported Outcomes Measurement Information System (PROMIS) depression, anxiety, fatigue, and alcohol use items in the context of clinical care for people living with HIV (PLWH), and to develop and assess new items as needed. METHODS: We conducted concept elicitation interviews (n = 161), item pool matching, prioritization focus groups (n = 227 participants), and cognitive interviews (n = 48) with English-speaking (~75 %) and Spanish-speaking (~25 %) PLWH from clinical sites in Seattle, San Diego, Birmingham, and Boston. For each domain we also conducted item review and prioritization with two HIV provider panels of 3-8 members each. RESULTS: Among items most highly prioritized by PLWH and providers were those that included information regarding personal impacts of the concept being assessed, in addition to severity level. Items that addressed impact were considered most actionable for clinical care. We developed additional items addressing this. For depression we developed items related to suicide and other forms of self-harm, and for all domains we developed items addressing impacts PLWH and/or providers indicated were particularly relevant to clinical care. Across the 4 domains, 16 new items were retained for further psychometric testing. CONCLUSION: PLWH and providers had priorities for what they believed providers should know to provide optimal care for PLWH. Incorporation of these priorities into clinical assessments used in clinical care of PLWH may facilitate patient-centered care.

Optimizing Surgical Treatment of Internationally Adopted Children With Cleft Lip and/or Palate: Understanding the Family Experience.

OBJECTIVE: To understand the experience of families with children undergoing cleft surgery following adoption from a country outside the United States. To identify factors, including the timing of surgery, that influence family function throughout the surgical experience. DESIGN: Semistructured qualitative interviews were conducted with parents of internationally adopted children postrepair of cleft lip and/or cleft palate and coded by a multidisciplinary study team. Mixed methods were used to contextualize themes derived from the parent interviews. RESULTS: Twenty parent interviews were conducted, and four core themes were identified: (1) parental anxieties prior to surgery, (2) considerations for the timing of surgery, (3) impact of the surgical experience on the child and family, and (4) modifiable sociocontextual factors. Parents considered a strong child bond with at least one parent and the ability of the child to communicate basic needs to be important before undergoing surgery. In retrospect, parents generally felt that the surgical experience did not have a negative impact on their child or their families and that the surgical experience may have even facilitated bonding and attachment with their child. Acceleration of family bonding was expressed more often by parents of children who were adopted at older than 2 years. CONCLUSIONS: In our study, parents reported that cleft surgery soon after international adoption did not appear to impair child bonding or adjustment. Specific family and provider factors that could optimize the experience for families were identified.

Patient and provider priorities for self-reported domains of HIV clinical care.

We sought to understand how HIV-infected patients, their providers, and HIV care researchers prioritize self-reported domains of clinical care. Participants rank-ordered two lists of domains. A modified Delphi process was used for providers and researchers. Approximately 25% of patients were interviewed to discuss rationale for rank order choices. List 1 included anger, anxiety, depression, fatigue, physical function, pain, and sleep disturbance. List 2 included alcohol abuse, cognitive function, HIV stigma, HIV and treatment symptoms, medication adherence, positive affect, sexual risk behavior, sexual function, social roles, spirituality/meaning of life, and substance abuse. Seventy-four providers, 80 HIV care researchers, and 66 patients participated. Patients ranked context-based domains, such as HIV stigma, more highly than providers, while health behaviors, such as drug or alcohol use, ranked lower. Patients described a need to address wider-context challenges such as HIV stigma in order to positively impact health behaviors. Divergent patient and provider priorities highlight the importance of incorporating views from all stakeholders and suggests the need for a care approach that more effectively addresses contextual barriers to adverse health behaviors.