Changes In Domain Scores Research Articles

Results From a Feasibility Study of Square-Stepping Exercise in Older Adults With Type 2 Diabetes and Self-Reported Cognitive Complaints to Improve Global Cognitive Functioning.

Adults with type 2 diabetes mellitus have an increased risk for dementia. Therefore, we proposed an intervention called the Square-stepping exercise (SSE) program to mitigate this risk. Our primary aim was to determine the feasibility of SSE in adults with type 2 diabetes and self-reported cognitive complaints. Our secondary aim was to determine whether 24 weeks of SSE improved cognition. Our tertiary aim was to determine whether SSE improved antisaccade reaction time, which is a measure of executive-related oculomotor control. Adults >49 years with type 2 diabetes and self-reported cognitive complaints were randomized to an SSE group (2×/week for 24 weeks of SSE) or a control group. Feasibility was assessed by recruitment and attendance. Participants were assessed at baseline, after 12 weeks and after 24 weeks for global cognitive function, memory, planning, reasoning and concentration via a computer-based cognitive battery (Cambridge Brain Sciences) and antisaccade reaction time (at baseline and 24 weeks). Participants in the SSE group were (mean [SD]): 65.9 (5.2) years old; 33% female; body mass index 33.3 kg/m2 (4.8) (n=12). Participants in the control group were 71.2 (6.9) years old; 31% female; body mass index 31.9 kg/m2 (4.6) (n=13). Over 24 weeks, attendance was 70.2% (SD 17.2) for 4/12 participants. There were 4 withdrawals and 1 adverse event. There were no differences in global cognitive functioning. The SSE group improved in planning domain change scores between 12 and 24 weeks (F=5.8, p=0.03, ηp2=0.28) compared to controls. In the SSE group, we found a nonsignificant improvement in antisaccade reaction time of 38 ms (SD 16), n=2, compared to 9 ms (SD 45) in the control group, n=8. SSE should be evaluated further to improve its feasibility in older adults with type 2 diabetes. This study provides preliminary evidence that SSE improves executive function in adults with type 2 diabetes and self-reported cognitive complaints.

Relational Health in Transitions: Female Adolescents in Chemical Dependency Treatment

ABSTRACTBackground: Adolescent substance use (SU) remains a serious problem. Inpatient, primary care, and self-treatment models for chemical dependency (CD) yield varying degrees of success impacting the sequelae of chronic or episodic SU. Relational engagement among adolescent substance users is a long known influential factor in the development, maintenance and transformation of addictive behaviors. Objectives: Following tenets of Relational-Cultural Theory and using the Relational Health Indices for Youth (RHI-Y), a validated survey tool for adolescents, we sought to measure relational health (RH) during times of transitions during CD treatment. This article addresses use of the tool and its potential for improving addictions research and practice. Methods: During 2015–2017 we explored differences in RH scores in adolescent girls entering inpatient CD treatment at three points: 51 at admission, 39 at discharge, and 13 at 3 months post-discharge. Data were analyzed using a generalized linear mixed model to compare changes in domain scores of RH. Results: Changes in RH scores were significant in the friend domain, but not the mentor and community domains. The RHI-Y shows promise in discerning RH change during transitions in CD treatment.

Assessment of nutrition and physical activity practices using self-report and observation in early care and education across multiple US states.

The National Early Care and Education Learning Collaboratives (ECELC) Project aims to promote healthy physical activity and nutrition environments, policies and practices in early care and education (ECE) programmes across multiple states. The present pilot study sought to assess changes to the physical activity and nutrition practices in a sub-sample of ECE programmes participating in the ECELC using the Environment and Policy Assessment and Observation (EPAO). Additionally, it sought to compare results with the Nutrition and Physical Activity Self-Assessment for Child Care (NAP SACC). Quasi-experimental pre-post pilot study where paired-sample t tests examined changes to physical activity and nutrition practices from pre-assessment to post-assessment (P<0·05). Pearson correlation coefficients examined change scores from EPAO compared with NAP SACC with statistical significance set at a two-sided α level of P<0·10 to account for sample size. The study occurred among ECE programmes. Pre-school classrooms in nineteen ECE programmes across four US states were observed. EPAO data demonstrated an increase in total score from pre-assessment to post-assessment (150 (sd 30) to 176 (sd 35)). NAP SACC change scores demonstrated little relationship with EPAO domain change scores, with exceptions in Nutrition Policy and Physical Activity Policy (r=-0·4 and -0·6, respectively). The overall improvements reported through the EPAO suggest participation in the ECELC resulted in changes in critical nutrition- and physical activity-related practices. However, considerable differences in data reported using the NAP SACC compared with the EPAO suggest subjective data should be interpreted with caution and objective measurement should be used when feasible.

Perceived impact of stroke six years after onset, and changes in impact between one and six years.

To examine the perceived impact of stroke between 1 and 6 years after stroke using the Stroke Impact Scale 3.0 (SIS). A prospective longitudinal study. A total of 100 individuals were assessed using the SIS 3.0 at 1 and 6 years after onset of stroke and clinically meaningful changes were explored. Changes in domain scores were calculated over time in relation to age, sex and stroke severity. The most impacted SIS domains after 6 years were Participation, Strength, Hand function, and Stroke recovery. Participants with moderate/severe stroke experienced a higher impact in all domains except Hand function and Stroke recovery, indicating more problems in everyday life, compared with those with mild stroke. Almost half of the participants had a clinically meaningful change in the domain Participation between 1 and 6 years. Those with moderate/severe stroke and the older age group experienced more negative clinically meaningful changes in several domains in comparison with those with mild stroke and the younger age group. The long-term perceived impact of stroke highlights the importance of appropriate rehabilitation interventions within several areas to reduce the long-term negative impact in everyday life.

The impact of concurrent granulocyte–macrophage colony-stimulating factor on quality of life in head and neck cancer patients: results of the randomized, placebo-controlled Radiation Therapy Oncology Group 9901 trial

The Radiation Therapy Oncology Group (RTOG) conducted a randomized, placebo-controlled trial evaluating the efficacy of GM-CSF in reducing mucosal injury and symptom burden from curative radiotherapy for head and neck (H&N) cancer. Eligible patients with H&N cancer receiving radiation encompassing ≥50% of the oral cavity or oropharynx received subcutaneous GM-CSF or placebo. Quality of life (QoL) was assessed using the RTOG-modified University of Washington H&N Symptom Questionnaire at baseline 4, 13, 26, and 48weeks from radiation initiation. Of 125 eligible patients, 114 were evaluable for QoL (58 GM-CSF, 56 placebo). Patient demographics, clinical characteristics, and baseline symptom scores were well balanced between the treatment arms. At the end of the acute period (13weeks), patients in both arms reported negative change in total symptom score indicating increase in symptom burden relative to baseline (mean -18.4 GM-CSF, -20.8 placebo). There was no difference in change in total symptom score (p>0.05) or change in mucous, pain, eating, or activity domain scores (p>0.01) between patients in the GM-CSF and placebo arms. Analysis limited to patients treated per protocol or with an acceptable protocol deviation also found no difference in change in total symptom score (p>0.05) or change in domain scores (p>0.01) between treatment arms. Provider assessment of acute mucositis during treatment did not correlate with patient-reported mucous domain and total symptom scores (p>0.05). GM-CSF administered concurrently during head and neck radiation does not appear to significantly improve patient-reported QoL symptom burden.

Changes in the impact of stroke between 3 and 12 months post-stroke, assessed with the Stroke Impact Scale.

To examine data collected using the Stroke Impact Scale 3.0 (SIS) at 3 and 12 months post-stroke, and to explore any clinically meaningful changes in everyday life in relation to age, gender and stroke severity. Prospective longitudinal study. A total of 204 persons were assessed using the SIS at 3 and 12 months after onset of stroke. Changes in domain scores were calculated over time and in relation to age, gender and stroke severity. The Strength, Hand Function and Participation domains had the highest perceived impact at 3 and 12 months, indicating problems in everyday life. Stroke recovery was perceived to be significantly higher at 12 than at 3 months irrespective of stroke severity, age or gender. The impact on the Strength and Emotion domains was significantly lower at 12 months than at 3 months. Most clinically meaningful changes, both positive and negative (± 15 points), were seen in the Participation domain and in Stroke recovery. Few changes were associated with age, gender or stroke severity. Both positive and negative clinically meaningful changes related to impact of stroke were found between 3 and 12 months post-stroke. Therefore it is important to pay close attention to patients' perceptions of their everyday life situation during rehabilitation and at discharge.

Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: Secondary analysis of a randomized, double-blind, placebo-controlled trial

Physical activity has been proposed as one of the most effective strategies to prevent cognitive decline. Protein supplementation may exert an additive effect. The effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly people was assessed in a secondary analysis. Two 24-week, double-blind, randomized, placebo-controlled intervention studies were carried out in parallel. Subjects performed a resistance-type exercise program of two sessions per week (n=62) or no exercise program (n=65). In both studies, subjects were randomly allocated to either a protein (2×15g daily) or a placebo drink. Cognitive functioning was assessed with a neuropsychological test battery focusing on the cognitive domains episodic memory, attention and working memory, information processing speed, and executive functioning. In frail and pre-frail elderly, resistance-type exercise training in combination with protein supplementation improved information processing speed (changes in domain score 0.08±0.51 versus −0.23±0.19 in the non-exercise group, p=0.04). Exercise training without protein supplementation was beneficial for attention and working memory (changes in domain scores 0.35±0.70 versus −0.12±0.69 in the non-exercise group, p=0.02). There were no significant differences among the intervention groups on the other cognitive tests or domain scores.

Changes in quality of life (WHOQOL-BREF) and addiction severity index (ASI) among participants in opioid substitution treatment (OST) in low and middle income countries: An international systematic review

BackgroundOpioid substitution treatment (OST) can increase quality of life (WHOQOL-BREF) and reduce addiction severity index (ASI) scores among participants over time. OST program participants have noted that improvement in quality of life is one of the most important variables to their reduction in drug use. However, there is little systematic understanding of WHOQOL-BREF and ASI domain changes among OST participants in low and middle-income countries (LMIC). MethodsUtilizing PRISMA guidelines we conducted a systematic literature search to identify OST program studies documenting changes in WHOQOL-BREF or ASI domains for participants in buprenorphine or methadone programs in LMIC. Standardized mean differences for baseline and follow-up domain scores were compared along with relationships between domain scores, OST dosage, and length of follow-up. ResultsThere were 13 OST program studies with 1801 participants from five countries eligible for inclusion in the review. Overall, statistically significant changes were noted in all four WHOQOL-BREF domain and four of the seven ASI domain scores (drug, psychological, legal, and family) documented in studies. Dosage of pharmacologic medication and length of follow-up did not affect changes in domain scores. ConclusionWHOQOL-BREF and ASI domain scoring is a useful tool in measuring overall quality of life and levels of addiction among OST participants. Coupled with measurements of blood-borne infection, drug use, relapse, and overdose, WHOQOL-BREF and ASI represent equally important tools for evaluating the effects of OST over time and should be further developed as integrated tools in the evaluation of participants in LMIC.

Identifying state-level policy and provision domains for physical education and physical activity in high school

BackgroundIt is important to quickly and efficiently identify policies that are effective at changing behavior; therefore, we must be able to quantify and evaluate the effect of those policies and of changes to those policies. The purpose of this study was to develop state-level physical education (PE) and physical activity (PA) policy domain scores at the high-school level. Policy domain scores were developed with a focus on measuring policy change.MethodsExploratory factor analysis was used to group items from the state-level School Health Policies and Programs Study (SHPPS) into policy domains. Items that related to PA or PE at the High School level were identified from the 7 SHPPS health program surveys. Data from 2000 and 2006 were used in the factor analysis. RESULTS: From the 98 items identified, 17 policy domains were extracted. Average policy domain change scores were positive for 12 policy domains, with the largest increases for “Discouraging PA as Punishment”, “Collaboration”, and “Staff Development Opportunities”. On average, states increased scores in 4.94 ± 2.76 policy domains, decreased in 3.53 ± 2.03, and had no change in 7.69 ± 2.09 policy domains. Significant correlations were found between several policy domain scores.ConclusionsQuantifying policy change and its impact is integral to the policy making and revision process. Our results build on previous research offering a way to examine changes in state-level policies related to PE and PA of high-school students and the faculty and staff who serve them. This work provides methods for combining state-level policies relevant to PE or PA in youth for studies of their impact.

Comparison of health-related quality of life in rheumatoid arthritis, psoriatic arthritis and psoriasis and effects of etanercept treatment

ObjectivesTo compare health-related quality of life (HRQoL) before and after treatment with etanercept in patients with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA) and psoriasis using spydergram representations.MethodsData...

Health-related quality of life changes associated with buprenorphine treatment for opioid dependence

Few studies have described improvement in health-related quality of life (HRQOL) associated with opioid dependence treatment with buprenorphine (ODT-B). To evaluate HRQOL changes in domain scores, physical and mental component summaries, and health utilities (HUs) associated with ODT-B using the Short Form 36 (SF-36). We assessed HRQOL changes in a substudy of a pharmacokinetic study that compared buprenorphine oral tablet and liquid dosage formulations over 16 weeks. Individuals, aged 18-65 years, were screened for opioid dependence. They were excluded if they would not agree to birth control or had a serious medical condition. Subjects received psychosocial counseling and weekly group therapy. The SF-36 was administered upon enrollment and at 4-week intervals. We used the SF-6D to estimate HUs. We performed intention to treat (ITT) analyses based on the last observation available for each subject. Paired t tests of each domain and HU, limited to remaining patients at each 4-week interval, were also conducted. Of 96 subjects enrolled, cumulative dropouts over time resulted in 80, 69, 59, and 44 subjects remaining at 4, 8, 12, and 16 weeks. There were no significant differences in opioid-positive urines, dropout rates, or dosage changes between formulations. In the ITT analyses, HRQOL improvements over time were bodily pain (62.1 vs. 69.1, P = 0.017), vitality (49.8 vs. 56.5, P = 0.001), mental health (59.9 vs. 66.0, P = 0.001), social function (66.4 vs. 74.7, P = 0.001), role emotional (59.4 vs. 71.9, P = 0.003), role physical (60.9 vs. 70.6, P = 0.005), and mental component summary (41.9 vs. 45.4, P<0.001). HU scores also improved (0.674 vs. 0.715, P = 0.001). Results from paired t tests, with only concurrently enrolled patients, showed similar improvements from baseline to 4, 8, 12, or 16 weeks. Buprenorphine, accompanied with psychosocial counseling, was associated with improved HRQOL and HUs.

Minimum Clinically Important Differences in the Cervical Spine Outcomes Questionnaire

The minimum clinically important difference is a clinically relevant threshold of improvement. A substantial clinical benefit is a threshold of change that correlates with clinically important improvement. The Cervical Spine Outcomes Questionnaire is a disease-specific, patient-reported outcomes instrument that was developed to be sensitive to changes associated with surgical treatment for degenerative cervical disc disease. To determine thresholds for change in these domain scores that are important from the patient's perspective, we estimated the minimum clinically important difference and substantial clinical benefit values for this questionnaire's domain scores. We evaluated 252 patients from the Cervical Spine Research Society Outcomes Study at their six-month follow-up visits after anterior cervical spine decompression and arthrodesis. Using a receiver operating characteristics curve, with the health transition item of the Short Form-36 as an anchor, we determined that the minimum clinically important difference (the value that maximized sensitivity and specificity to differentiate the "somewhat better" and "much better" responses from others) and the substantial clinical benefit (the value that maximized sensitivity and specificity to differentiate the "much better" response from others) for our questionnaire's domain scores. Responses were scaled between 0 and 1 point; higher scores denoted more severe impairment. Patient and clinical characteristics were tested to determine their influence on score changes. The minimum clinically important difference ranged from 0.13 point (for functional disability) to 0.24 point (for arm/shoulder pain). The substantial clinical benefit score ranged from 0.20 point (for functional disability or physical symptoms other than pain) to 0.30 point (for neck or arm/shoulder pain). Age, sex, and duration of current symptoms were not associated with change in our questionnaire's domain scores. A 0.13-point change in the functional disability domain score indicated a clinically important difference in a self-reported outcome after anterior cervical spine surgery. A 0.30-point change in neck pain after surgery indicated a clinically important clinical benefit. This information, coupled with previous reports of the psychometric stability of the Cervical Spine Outcomes Questionnaire, should increase the clinical utility of this patient-reported outcomes instrument.

Patient Satisfaction After Surgical Correction of Adolescent Idiopathic Scoliosis

Longitudinal cohort. The purpose of this study is to evaluate the relationship between change in SRS-22 domain scores and satisfaction with management in patients who underwent surgical correction for adolescent idiopathic scoliosis (AIS). The Scoliosis Research Society-22 (SRS-22) is a widely used instrument to measure clinical outcomes in patients with scoliosis. The relationship between patient satisfaction and changes in domain scores in the SRS-22 has not been previously reported. This is a longitudinal cohort of 745 patients with AIS who underwent surgical correction and had completed SRS-22 preoperative and 2 years postoperative. Patients who had a previous spine surgery were excluded. Wilcoxon tests were used to compare preop and 2-year postop scores. Spearman correlations were used to evaluate associations between change in SRS-22 domain scores from preoperative to 2 years postoperative and the 2-year SRS Satisfaction score. There were 622 females and 123 males with a mean age of 14.2 years and a mean Cobb angle of 54°. There was a statistically significant difference between paired preoperative and 2-year postoperative SRS domain scores. Spearman correlations between the change in SRS domain scores and the SRS Satisfaction score at 2 years postoperative were statistically significant but were low to moderate: Appearance = 0.284, Activity = 0.172, Pain = 0.260, Mental = 0.202, and Total = 0.398. Although there is a statistically significant change in all the SRS domain scores from preoperative to 2 years postsurgical correction of AIS, there was low to moderate associations between the change in any of the domain scores and patient satisfaction with treatment. This may be attributable to the prominent ceiling effect in the Satisfaction domain, or the lack of responsiveness of the SRS-22 to measure clinically relevant changes in activity, pain and mental health 2 years after correction of scoliosis in the adolescent population.

Effect of intraoral low‐level laser therapy on quality of life of patients with head and neck cancer undergoing radiotherapy

Low-level laser therapy has been used to reduce complications of head and neck cancer treatment. The aim was to assess the impact of laser in the quality of life (QOL) of patients receiving radiotherapy. Sixty outpatients were randomly assigned into 2 groups. The laser group received applications and the placebo group received sham laser. QOL was assessed using the University of Washington QOL questionnaire. A repeated-measures analysis of variance (ANOVA) was used for comparisons of overall QOL scores and Mann-Whitney test compared changes in domain scores. A decrease in QOL scores was observed in both groups and the reduction in the laser group was significantly lower (p < .01). Changes in QOL scores regarding pain, chewing, and saliva domains were evident in the placebo group. Both health-related QOL and overall QOL were rated higher by patients who received laser therapy. Laser therapy reduces the impact of radiotherapy on the QOL of patients with head and neck cancer.

1672 EFFICACY AND SAFETY OF ORAL MIRODENAFIL IN THE TREATMENT OF ERECTILE DYSFUNCTION IN DIABETIC MEN IN KOREA: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL

INTRODUCTION AND OBJECTIVES: Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED).To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of erectile dysfunction(ED) in Korean men with diabetes. METHODS: A multicenter, randomized, double-blind, placebocontrolled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). RESULTS: After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared to placebo group (9.3 vs. 1.4, P 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P 0.0001) and Q4 (1.7 vs. 0.3, P 0.0001) were higher compared to the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P 0.0003), SEP3 (68.9% vs. 22.3%, P 0.0001). Difference in GAQ i°YESi responses was also significant (76.9% vs. 19.1%, P 0.0001). Normal EF domain scores (iA26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P 0.0031). As for LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. CONCLUSIONS: Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.

Efficacy and Safety of Oral Mirodenafil in the Treatment of Erectile Dysfunction in Diabetic Men in Korea: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

Mirodenafil is a newly developed selective phosphodiesterase type 5 (PDE5) inhibitor for the treatment of erectile dysfunction (ED). To evaluate the efficacy, safety and tolerability of mirodenafil in the treatment of ED in Korean men with diabetes. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study was conducted with 112 subjects who were randomized to either placebo or mirodenafil 100 mg on demand for 12 weeks. Primary efficacy variable was the erectile function (EF) domain scores of the International Index of Erectile Dysfunction (IIEF) questionnaire. Secondary efficacy variables included change in the scores of IIEF question 3 and 4 (IIEF Q3 and Q4) from baseline, change in all domain scores in the IIEF from baseline, Sexual Encounter Profile questions 2 and 3 (SEP2 and SEP3), the Global Assessment Question (GAQ) and the Life Satisfaction Checklist (LSC). After 12 weeks of treatment, mirodenafil group showed significantly greater change in the IIEF-EF domain score from baseline compared with the placebo group (9.3 vs. 1.4, P < 0.0001). The changes from baseline in the mirodenafil group in IIEF Q3 (1.7 vs. 0.4, P < 0.0001) and Q4 (1.7 vs. 0.3, P < 0.0001) were higher compared with the placebo group. Differences between the mirodenafil and placebo groups were significant in the SEP2 (82.0% vs. 55.2%, P = 0.0003), SEP3 (68.9% vs. 22.3%, P < 0.0001). Difference in GAQ "YES" responses was also significant (76.9% vs. 19.1%, P < 0.0001). Normal EF domain scores (≥ 26) at study end were achieved by 32.7% and 9.4% in the mirodeniafl and placebo groups, respectively (P = 0.0031). As for the LSC scores, the mirodenafil group showed significantly greater improvements in sexual life and partner relationship than the placebo group. Most treatment-associated AEs were mild that resolved spontaneously. Mirodenafil is an effective and well-tolerated agent for the treatment of diabetic patients with ED in Korea.

The Oxford Ankle Foot Questionnaire for children: responsiveness and longitudinal validity

To evaluate how scores from the Oxford Ankle Foot Questionnaire change over time and with treatment using both distribution-based and anchor-based approaches. Eighty children aged 5-16 and their parent or career completed questionnaires at orthopaedic or trauma outpatient clinics. They were asked to complete and return a second set of questionnaires again within 2 weeks (retest), and then mailed a third set of questionnaires to complete again after 2 months (follow-up). The follow-up questionnaires included a global rating of change 'transition' item. Child- and parent-reported mean domain scores (Physical, School & Play, and Emotional) were all stable at retest, whereas positive mean changes were observed at follow-up. As we hypothesised, trauma patients had poorer scores than elective patients at baseline, and showed greater improvement at follow-up. For trauma patients, mean changes in per cent scores were large (scores improved between 40 and 56 for the Physical and School & Play domains, and 17 and 21 for Emotional); all effect sizes (ES) were large (>0.8). For elective patients, the mean improvement in per cent scores were more moderate (Physical: child 10, ES = 0.4, parent 11, ES = 0.5; School & Play child 0, ES = 0, parent 9 ES = 0.4; Emotional: child 6, ES = 0.2; parents 8, ES > 0.3). Minimal detectable change (MDC(90)), an indication of measurement error, ranged from 6 to 8. Half the standard deviation of baseline scores ranged from 11 to 18. Minimal important difference could only be calculated for elective patients (9 child and 13 parent ratings), these ranged from 7 to 17. The findings support the responsiveness and longitudinal validity of the scales. Changes in domain scores of, or exceeding, the MDC(90) (6-8) are likely to be beyond measurement error; further work is required to refine the estimate of change that can be considered important.

The SF-36 and SGRQ: Validity and first look at minimum important differences in IPF

Health-related quality of life (HRQL) is an important outcome in drug trials. Little is known about how the Short Form-36 (SF-36) and Saint George's Respiratory Questionnaire (SGRQ) perform in idiopathic pulmonary fibrosis (IPF). To examine the validity of the SF-36 and SGRQ and to determine scores from each that would constitute a minimum important difference (MID). We analyzed data from a recently completed trial that enrolled subjects with well-defined IPF who completed the SF-36, SGRQ, and Baseline/Transition Dyspnea Index at baseline and six months. We compared mean changes in HRQL scores between groups of subjects whose disease severity changed over six months according to clinical anchors (FVC, DLCO, and dyspnea). We estimated the MID for each domain by using both anchor- and distribution-based approaches. Results supported the validity of the SF-36 and SGRQ for use in longitudinal studies. Mean changes in domain scores differed significantly between subjects whose clinical status improved and those whose clinical status declined according to the anchors. MID estimates for the SF-36 ranged from 2-4 points and from 5-8 points for the SGRQ. In IPF, the SF-36 and SGRQ possess reasonable validity for differentiating subjects whose disease severity changes over time. More studies are needed to continue the validation process, to refine estimates of the MIDs for the SF-36 or SGRQ, and to determine if a disease-specific instrument will perform better than either of these.

Vaginal prolapse repair surgery augmented by ultra lightweight titanium coated polypropylene mesh

Objectives To determine the safety and efficacy of ultra lightweight titanium coated polypropylene mesh to augment conventional vaginal prolapse repair in women with recurrent symptomatic prolapse stage II or more or primary prolapse stage III or more. Study design A prospective observational cohort study was performed at two urogynecological centres in The Netherlands. Women with recurrent symptomatic prolapse at least stage II or primary vaginal prolapse ICS POP stage III or more participated in the study. POP-Q and validated urogynecological questionnaires were used pre- and post-operatively. Outcome measures were mesh-related morbidity and prolapse recurrence, defined as ICS POP stage II, as well as changes in domain scores on urogenital distress- and defaecatory distress inventory (UDI and DDI), incontinence impact questionnaire (IIQ) as well as sexual functioning. Wilcoxon's signed ranks test for paired variables and 95% confidence intervals, respectively were used to analyse these data. Results The study group comprised 71 patients with a median follow-up of 9 months (6–14). Mesh erosions were detected in four patients (5.6%), all on the posterior vaginal wall. After Ti-mesh ® augmentation in 14 patients (36%) the anterior vaginal wall and in 7 patients (18%) the posterior vaginal wall, was categorised as ICS POP stage II and were thus considered failures. UDI and DDI domain scores all improved significantly, except for the domains of incontinence and pain, respectively. Three out of five domains of the IIQ showed significant improvement. Surgery did not have any significant negative impact on sexual functioning. Conclusion Ultra lightweight titanized polypropylene mesh to augment conventional vaginal prolapse repair surgery showed minimal morbidity, but no additional value compared to conventional surgery at short-term follow-up.

Effect of Intracapsular Tonsillectomy on Quality of Life for Children With Obstructive Sleep-Disordered Breathing

To assess the change in disease-specific quality of life (QOL) in pediatric patients with obstructive sleep-disordered breathing (OSDB) secondary to adenotonsillar hypertrophy after powered intracapsular tonsillectomy and adenoidectomy. Prospective outcomes study. Hospital-based pediatric otolaryngology practice. Fifty children with a mean age of 4.5 years who had a clinical diagnosis of OSDB. A caregiver of qualifying patients completed a validated QOL survey of pediatric obstructive sleep apnea, the OSA-18 (Obstructive Sleep Apnea-18), preoperatively and 3 months and 1 year postoperatively. The OSA-18 mean change scores. The mean (SD) total OSA-18 change score at the 3-month follow-up visit was 2.3 (1.2) and at the 1 year follow-up visit was 2.2 (1.3). The total and individual domain change scores were significantly improved at both postoperative intervals (P<.001 for all). There were no significant changes in the total or domain change scores between the intervals. The total change score was not significantly associated with either tonsil size or tonsil position. The OSDB-related QOL is significantly improved after powered intracapsular tonsillectomy and adenoidectomy, and this improvement remains stable even after 1 year.