Definition Of Treatment Success Research Articles

Disease resolution following treatment of peri-implant diseases: A systematic review.

The aim of this PRISMA-compliant systematic review was to analyze the evidence pertaining to disease resolution after treatment of peri-implant diseases (PROSPERO: CRD42022306999) with the following PICO question: what is the rate of disease resolution following non-surgical and surgical therapy for peri-implant diseases in adult human subjects? A literature search to identify studies that fulfilled a pre-established eligibility criteria was conducted. Data on primary therapeutic outcomes, including treatment success, rate of disease resolution and/or recurrence, as well as a variety of secondary outcomes was extracted and categorized. Fifty-five articles were included. Few studies investigated the efficacy of different non-surgical and surgical therapies to treat peri-implant diseases using a set of pre-defined criteria and with follow-up periods of at least one year. The definition of treatment success and outcomes of disease resolution differed considerably among the included studies. Treatment of peri-implant mucositis was most commonly reported to be successful in arresting disease progression for ≤60% of the cases, whereas most studies on peri-implantitis treatment reported disease resolution occurring in <50% of the fixtures. In conclusion, disease resolution is generally unpredictable and infrequently achieved after the treatment of peri-implant diseases. A great variety of definitions have been used to define treatment success. Notably, percentages of treatment success and disease resolution were generally underreported. The use of standardized parameters to evaluate disease resolution should be considered an integral component in future clinical studies.

Improved Physical and Mental Health After a Combined Lifestyle Intervention with Cognitive Behavioural Therapy for Obesity.

Obesity is a multifactorial, chronic, progressive disease associated with decreased health-related quality of life, comorbidities, and increased mortality risk. Lifestyle interventions, focusing on dietetics, physical exercise, and behavioral therapy, are a cornerstone of therapy. Despite this very multidisciplinary treatment approach, the definition of treatment success is often based only on a weight loss of ≥ 5%. However, the heterogeneous nature of obesity may necessitate a more comprehensive approach to assessing treatment effects. Here, we describe changes in physiological, psychological, and behavioral health after a multidisciplinary combined lifestyle intervention (CLI). Additionally, we investigated whether these changes were related to weight loss. This prospective observational longitudinal study comprised 96 adults with obesity (73 women, 81 Caucasian) participating in a CLI at the Obesity Center CGG, Erasmus University Medical Center, Rotterdam, the Netherlands. The 1.5-year intervention comprised multidisciplinary professional guidance towards a healthy diet, increased physical activity, and included cognitive behavioral therapy. Physiological health outcomes, psychological well-being, eating behavior, and physical activity were assessed after ten weeks and 1.5 years and compared to baseline. An average of 5.2% weight loss (-6.0 kg) was accompanied by a mean 9.8% decrease in fat mass (-5.9 kg; both P < 0.001) and significant improvements in metabolism, hormonal status, and immune parameters (all P < 0.05). Moreover, we observed decreased psychopathology, increased quality of life, and decreased disordered eating (all P < 0.05). Weight loss correlated with most metabolic changes (all P < 0.05) but not with most psychological/behavioral changes. Combined lifestyle intervention in patients with obesity was accompanied by significant improvements in body weight and body composition along with cardiometabolic, endocrine, immunological, psychological, and behavioral improvements. Interestingly, most changes in psychological and behavioral health occurred independently of weight loss. Obesity treatment success should be evaluated based on a combination of physical and patient-reported outcomes rather than weight loss alone.

2243. Patient Perceptions of Treatment Success in Uncomplicated Urinary Tract Infection

Abstract Background Regulatory guidance for developing uncomplicated urinary tract infection (uUTI) treatments requires endpoints assessing uUTI symptom resolution present at trial entry. The meaningfulness of this endpoint and definition of treatment success is rarely explored with patient-experience data (PED), and there is a paucity of PED in the literature. Methods This cross-sectional interview study included English- and Spanish-speaking women aged ≥ 12 years with confirmed uUTI diagnosis within 14 days of screening. Interviews were recorded, transcribed and analyzed using qualitative methods. Participants were asked questions to elicit spontaneous and probed reports of uUTI symptoms and how these impacted health-related quality of life. Participants provided descriptions of symptom resolution, treatment success and evaluated a 4-point scale assessing dysuria, urinary frequency, urinary urgency and suprapubic pain. They were asked if the scale contents captured their uUTI experience, including assessing meaningful treatment effect. Results Overall, 30 participants were included, mean age 40 (range: 12–61) years. Urgency was the most common symptom reported (n=29, Table 1), and nearly all (n=29) participants reported their recent uUTI affected mood/emotions (Table 2). Participants reported the relevance of symptoms and the meaning of the points on the scale (Table 3). At interview, 24 participants scored each symptom as “none” and reported this was meaningful/important. Most participants (n=27) said they would not consider treatment successful if they still experienced ≥ 1 symptom by the end of the treatment period; however, almost half (n=14) agreed that with severe symptoms, the smallest meaningful improvement would be moving from severe to moderate. A limitation of this study is that participants were not asked about underlying symptoms between episodes of uUTI. Table 1.Patient-reported uUTI symptoms (N=30)*The symptom was not probed during the interview but was spontaneously reported by the participant(s). Abbreviation: uUTI, uncomplicated urinary tract infection.Table 2.Patient-reported impacts of uUTI (N=30)*The impact was not systematically probed during the interview but was spontaneously reported by the participant; †daily activities included cleaning, shopping, caring for children, exercising, or playing sports; ‡physical activities included walking, hiking, playing sports, exercising, and going to the gym; §adolescents (n=5) were not asked about intimate relationships.Abbreviation: uUTI, uncomplicated urinary tract infection.Table 3.Sample of quotations from patient interviewsAbbreviations: UTI, urinary tract infection; uUTI, uncomplicated urinary tract infection. Conclusion Participants reported numerous impacts of uUTI. Definitions of symptom resolution and treatment success should be established with PED, with complete symptom resolution considered the most valued. The regulatory definition relevance of symptom resolution for uUTI and the content validity of a scale to assess symptom resolution was confirmed by participants. Disclosures Claire L. Trennery, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Susan Martin, MSPH, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Katherine Kosa, MSc, GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370|RTI Health Solutions: Employee of RTI Health Solutions which received funding from GlaxoSmithKline plc. to conduct this study Lydia Demetriou, MSc, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study 217370 Ashish V. Joshi, PhD, GlaxoSmithKline plc.: Employee and shareholder|GlaxoSmithKline plc.: GlaxoSmithKline plc.-sponsored study.

Magnetic Resonance Imaging Characteristics Associated with Treatment Success from Basivertebral Nerve Ablation: An Aggregated Cohort Study of Multicenter Prospective Clinical Trials Data.

ObjectiveInvestigate associations between endplate and motion segment magnetic resonance imaging (MRI) characteristics and treatment outcomes following basivertebral nerve radiofrequency ablation (BVN RFA) in patients with clinically suspected vertebral endplate pain (VEP).DesignAggregated cohort study of 296 participants treated with BVN RFA from three prospective clinical trials.MethodsBaseline MRI characteristics were analyzed using stepwise logistic regression to identify factors associated with treatment success. Predictive models used three definitions of treatment success: (1) ≥50% low back pain (LBP) visual analog scale (VAS), (2) ≥15-point Oswestry Disability Index (ODI), and (3) ≥50% VAS or ≥15-point ODI improvements at 3-months post-BVN RFA.ResultsThe presence of lumbar facet joint fluid (odds ratio [OR] 0.586) reduced the odds of BVN RFA treatment success in individuals with clinically suspected VEP. In patients with a less advanced degenerative disc disease (DDD) profile, a > 50% area of the endplate with bone marrow intensity changes (BMIC) was predictive of treatment success (OR 4.689). Both regressions areas under the curve (AUCs) were under 70%, indicating low predictive value. All other vertebral endplate, intervertebral disc, nerve roots facet joint, spinal segmental alignment, neuroforamina, lateral recesses, and central canal MRI characteristics were not associated with BVN RFA success.ConclusionsIn patients with vertebrogenic low back pain with Modic changes, the presence of degenerative findings of the anterior and posterior column was not associated with a clinically important impact on BVN RFA treatment success. None of the models demonstrated strong predictive value, indicating that the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of pain remain the most useful patient selection factors for BVN RFA.

The Relationship Between Patient Demographic and Clinical Characteristics and Successful Treatment Outcomes After Basivertebral Nerve Radiofrequency Ablation: A Pooled Cohort Study of Three Prospective Clinical Trials.

ObjectiveMultiple studies have demonstrated the safety and effectiveness of basivertebral nerve radiofrequency ablation (BVN RFA) for improving low back pain related to the vertebral endplate. However, the influence of patient demographic and clinical characteristics on treatment outcome is unknown.DesignPooled cohort study of three clinical trials of patients with vertebral endplate pain identified by Type 1 and/or Type 2 Modic changes and a correlating presentation of anterior spinal element pain.SettingThirty-three global study centers.SubjectsPatients (n = 296) successfully treated with BVN RFA.MethodsParticipant demographic and clinical characteristics were analyzed with stepwise logistic regression to identify predictors of treatment success. Three definitions of treatment success were defined: 1) ≥50% visual analog scale pain improvement, 2) ≥15-point Oswestry Disability Index (ODI) improvement, and 3) ≥50% visual analog scale or ≥15-point ODI improvement from baseline.ResultsLow back pain of ≥5 years’ duration and higher ODI scores at baseline increased the odds of treatment success, whereas baseline opioid use and higher Beck Depression Inventory scores reduced these odds. However, the three regression models demonstrated receiver-operating characteristics of 62–70% areas under the curve, and thus, limited predictive capacity.ConclusionsThis analysis identified no demographic or clinical characteristic that meaningfully increased or reduced the odds of treatment success from BVN RFA. On the basis of these findings and the high response rates from the three analyzed trials, we recommend the use of objective imaging biomarkers (Type 1 and/or 2 Modic changes) and a correlating presentation of anterior spinal element pain to determine optimal candidacy for BVN RFA.

Values of Retinoblastoma Survivors and Parents Regarding Treatment Outcomes: A Qualitative Study.

Retinoblastoma is an aggressive pediatric eye cancer. Patient-reported outcome measures reveal important insights into how patients perceive their own health. Currently, there is no widely used or validated measure for assessment of retinoblastoma outcomes. The purpose of this research was to uncover which treatment outcomes that retinoblastoma survivors and their parents value, to inform the development of a future measure. This qualitative, cross-sectional study included retinoblastoma survivors age 6 years and older and parents of retinoblastoma survivors. Participants who did not demonstrate fluency in English were excluded. Study participants participated in semistructured interviews or focus groups, either in person at The Hospital for Sick Children, Toronto, Canada, or through secure videoconference, between March 3, 2019, and January 25, 2020. Iterative rounds of opening coding, codebook development, and coresearcher analysis were used to identify key emergent themes and subthemes. Seventeen adults participated in six focus groups. Nine pediatric survivors participated in individual interviews. Four common themes emerged from all participant groups: (1) definition of treatment success, (2) enucleation-acceptance and challenges, (3) treatment outcomes to measure, and (4) need for outcome reporting. An additional, unique theme was identified in all pediatric discussions: worries and coping mechanisms. Treatment outcomes deemed valuable were related to the following domains: psychosocial outcomes, daily functioning, functional vision, retinoblastoma education, cosmetic outcomes, and secondary eye conditions. This study represents the first stage in the development of a retinoblastoma-specific patient-reported outcome measure. The findings reveal insight into what outcomes are valued by survivors after treatment and offer promise to improve outcomes assessment for retinoblastoma.

Early first-line treatment response and subsequent disability worsening in relapsing-remitting multiple sclerosis.

Treatment success in relapsing-remitting multiple sclerosis (RRMS) is generally determined using relapse frequency and magnetic resonance imaging (MRI) activity in the first 6 or 12months on treatment. The association of these definitions of short-term treatment success with disability worsening and disease activity in the longer term is unclear. In this study, we investigated risk factors associated with early first-line treatment failure in RRMS, and the association of early treatment failure with subsequent disability worsening or "no evidence of disease activity" (NEDA-3) status. We used data from CombiRx (clinicaltrials.gov identifier NCT00211887) to investigate risk factors associated with early treatment failure, and the association of early treatment failure at 6 and 12months with subsequent disability worsening or NEDA-3 at 36months. CombiRx included 1008 treatment-naïve participants with RRMS, who were randomly assigned to treatment with glatiramer acetate, interferon beta, or the combination of both. Early treatment failure at 6 or 12months by several definitions was associated with NEDA-3 failure at 36months, but not with subsequent disability worsening at 36months. Expanded Disability Status Scale (EDSS) was the only baseline characteristic associated with the risk of disability worsening at 36months. Approximately 70% of NEDA-3 failures occurred due to MRI activity, and <10% occurred due to EDSS worsening. Our investigation shows that current definitions of early treatment failure in RRMS are unrelated to patient-relevant disability worsening at 36months of follow-up. Further research into useful definitions of treatment success and failure in RRMS is needed.

Measuring What Matters-A Holistic Approach to Measuring Well-Being in Endometriosis.

Endometriosis is a common condition which affects women in a number of ways and impairs their ability to live a full and meaningful life. Evaluative research has traditionally taken its cue from a medical approach which has forced women to choose one area of functioning as their primary concern, and tended to use a narrow definition of treatment success which ignores general well-being. While recent trials have included quality of life (QOL) measures as outcomes, these have not been able to capture the totality of the impact of the disease and its treatment on a woman's capability to do what she might want to do and be who she might want to be. A capability approach might overcome this barrier, but the available tools will need to be refined and validated in women with endometriosis before this can be integrated within everyday clinical and research practice.

Choice and Trade-offs: Parent Decision Making for Neurotechnologies for Pediatric Drug-Resistant Epilepsy

This qualitative study investigated factors that guide caregiver decision making and ethical trade-offs for advanced neurotechnologies used to treat children with drug-resistant epilepsy. Caregivers with affected children were recruited to semi-structured focus groups or interviews at one of 4 major epilepsy centers in Eastern and Western Canada and the USA (n = 22). Discussions were transcribed and qualitative analytic methods applied to examine values and priorities (eg, risks, benefits, adherence, invasiveness, reversibility) of caregivers pertaining to novel technologies to treat drug-resistant epilepsy. Discussions revealed 3 major thematic branches for decision making: (1) features of the intervention-risks and benefits, with an emphasis on an aversion to perceived invasiveness; (2) decision drivers-trust in the clinical team, treatment costs; and (3) quality of available information about neurotechnological options. Overall, caregivers' definition of treatment success is more expansive than seizure freedom. The full involvement of their values and priorities must be considered in the decision-making process.

Misoprostol treatment for early pregnancy loss: an international survey

Research questionWhat is the global variability in misoprostol treatment for the management of early pregnancy loss (EPL)? DesignAn international web-based survey of fertility specialists and obstetrics and gynaecology clinicians was conducted between August and November 2020. The survey consisted of 16 questions addressing several aspects of misoprostol treatment for EPL. ResultsOverall, 309 clinicians from 80 countries participated in the survey, of whom 67.3% were fertility specialists. Nearly one-half (47.9%) of the respondents let the patient choose the first line of treatment (expectant management, misoprostol treatment or surgical aspiration) according to her own preference. The 248 respondents who administer misoprostol in their daily practice were asked further questions; 59.7% of them advise patients to take the medication at home. The most common dose and route of administration is 800 µg administered vaginally. Only 28.6% of participants use mifepristone pretreatment. Variation in the timing of the first follow-up visit after misoprostol administration was wide, ranging from 24 h to 1 week in most clinics. In case of incomplete expulsion, only 42.3% of the respondents routinely administer a second dose. The timing of the final visit and the definition of successful treatment also differed greatly among respondents. ConclusionsThere is large variability in the use of misoprostol for the management of EPL. High-quality research is necessary to examine several aspects of the treatment. Particularly, the timing and effectiveness of a second dose administration and the criteria to decide on treatment failure or success deserve more research in the future.

Patient-Defined Treatment Success: Perspectives of Patients With Advanced-Stage Lung Cancer.

In the United States, lung cancer accounts for 14% of cancer diagnoses and 28% of cancer deaths annually. Because no cure exists for advanced lung cancer, the primary treatment goal is to prolong survival. The study aim was to determine whether individual preferences, characteristics, and treatment experiences affect the meaning of treatment success. A quantitative study using an observational, longitudinal cohort of patients with advanced stage non-small-cell lung cancer was conducted. Data sources included medical records and patient interviews. Data were analyzed using χ2, Fisher's exact, and McNemar's tests, as well as logistic regressions. At the first interview of 235 individuals, 12% considered survival alone as their definition of treatment success; others defined treatment success as survival plus other aspects, such as quality of life and reaching an important personal goal. As they moved through chemotherapy, 47% of the patients changed their definition of treatment success. Bivariate analysis showed that patients with lower incomes tended to be more likely to change their definition of treatment success compared with their counterparts with higher income (P = .0245). By taking chemotherapy, patients expect to increase their odds of survival and want to maintain the quality of life and functionality. A patient's definition of treatment success is often changing as treatment continues, making it appropriate to ensure patient-provider communication throughout their clinical care. The study results are limited to patients with advanced non-small-cell lung cancer and drawn from a predominantly white patient population, mainly from the US Midwest.

Predictors of functional response and remission with desvenlafaxine 50 mg and 100 mg: a pooled analysis of randomized, placebo-controlled studies in patients with major depressive disorder.

The value of early functional improvement at week 2 for predicting subsequent functional outcomes at week 8 was assessed in a pooled analysis of patients with major depressive disorder (MDD) treated with desvenlafaxine (50 or 100mg/d) or placebo. Data were pooled from eight double-blind, placebo-controlled studies of desvenlafaxine 50mg/d or 100mg/d for the treatment of MDD. Optimal week-2 improvement thresholds in Sheehan Disability Scale (SDS) score, which best predicted week-8 treatment success, were determined using receiver operating characteristic (ROC) analysis. Four definitions of treatment success were established: (1) functional response, (2) functional/depression response, (3) functional remission, and (4) functional/depression remission. Odds ratios (ORs) of early improvement for prediction (based on thresholds determined in the ROC analysis) of week-8 treatment success were computed using logistic regression models. Functional early improvement thresholds of 17%-32% were predictive of week-8 treatment success across treatment groups and definitions of treatment success. Optimal thresholds were higher for more stringent definitions. Negative predictive value exceeded positive predictive value, indicating that failure to achieve early functional improvement was more informative about later treatment success than was the achievement of early functional improvement. Early change in SDS was a highly significant predictor of functional response/remission (ORs, 4.981-8.737; all p < 0.0001); the interaction between treatment and early functional improvement was not significant. Early improvement in SDS total score was predictive of functional outcomes for patients treated with desvenlafaxine 50mg, desvenlafaxine 100mg, or placebo.

Controversies in Obstructive Sleep Apnea Surgery.

Obstructive sleep apnea (OSA) is a common chronic disease characterized by repetitive pharyngeal collapse during sleep. OSA is associated with cardiovascular disease and increased mortality, among other issues. Continuous positive airway pressure (CPAP) is considered first line therapy for OSA, but is not always tolerated. Both non-surgical and surgical alternative management strategies are available for the CPAP intolerant patient. This article explores controversies surrounding airway evaluation, definition of successful treatment, and surgical management of the CPAP intolerant patient with moderate to severe OSA. Controversies specific to maxillomandibular advancement (MMA) are also discussed.

Systemic treatments for alopecia areata: A systematic review.

A range of systemic treatments are used for alopecia areata with variable evidence supporting efficacy. In this systematic review, we evaluated the evidence surrounding systemic treatments for alopecia areata, alopecia totalis and alopecia universalis. A systematic search was conducted of the peer-reviewed literature published between 1946 and March 2018 via Medline, Embase, Amed, the Cochrane Central Register of Controlled Trials, PsychINFO and Lilacs. All randomised controlled trials (RCTs) that evaluated the effectiveness of systemic treatments for individuals with alopecia areata, totalis or universalis were included. Sixteen studies were included with a total of 768 participants. We found eight placebo-controlled RCTs, three RCTs comparing two systemic treatments and five RCTs comparing three treatments. A total of 15 different systemic therapies were investigated. The most frequently investigated therapy was oral prednisolone pulse therapy and oral inosiplex. There was significant variability in the definition of treatment success. No study evaluated the impact of pharmacotherapy on quality of life using complete quantitative quality of life instruments. Adverse events were reported in 13 studies and were corticosteroid related or otherwise well tolerated. Relapse rates were considerable in the four studies that reported this outcome. There is currently no specific systemic therapy that is supported by robust body of evidence from RCTs. The current evidence suggests efficacy of oral prednisolone pulse therapy and oral inosiplex. Evidence does not support the use of oral zinc sulphate, alefacept and efalizumab. Future RCTs should be adequately powered and employ clearly defined clinical response endpoints to allow future meta-analyses.

Defining Treatment Success After 2-Stage Exchange Arthroplasty for Periprosthetic Joint Infection

BackgroundTwo-stage exchange arthroplasty remains the preferred surgical treatment method for patients with chronic periprosthetic joint infection (PJI). The success of this procedure is not known exactly as various definitions of success have been used. This study aimed at analyzing the difference in outcome following 2-stage exchange arthroplasty using different definitions for success. MethodsA retrospective study of 703 patients with PJI who underwent resection arthroplasty and spacer insertion between January 1999 and June 2015 was performed. Chart review identified intraoperative cultures at the time of spacer, reimplantation, and any subsequent reinfections or surgeries following spacer insertion. After applying the exclusion criteria, a total of 570 patients were included in the analysis. Five definitions of treatment success were assessed: (1) Delphi consensus success, (2) modified Delphi consensus success, (3) microbiological success, (4) implant success, and (5) surgical success. ResultsOf the 570 patients with PJIs, 458 were reimplanted at a mean of 4.1 months. Mortality was 13.9% with 6.7% occurring before reimplantation. Treatment success was highly variable depending on the definition used (54.2%-88.9%). In 19.6% of PJI cases, the Delphi consensus definition could not be assessed as reimplantation never occurred. Furthermore, 67.0% of these patients underwent reoperations, which may not be accounted for in the Delphi consensus definition. ConclusionTreatment success rates vary dramatically depending on the definition used at our institution. We hope these definitions can help bring forth awareness for standardized reporting of outcomes, but further validation and agreement of these definitions among surgeons and infectious disease physicians is crucial.

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An optimal definition for urethroplasty success should include both anatomic and functional outcomes. 1 Erickson B.A. Ghareeb G.M. Definition of successful treatment and optimal follow-up after urethral reconstruction for urethral stricture disease. Urol Clin North Am. 2017; 44: 1-9 Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar To objectively assess anatomic success, ideally all patients should undergo cystoscopy at follow up. However, previous data show that about half of the patients will not return for a cystoscopic follow-up at 1 year. 2 Erickson B.A. Elliott S.P. Voelzke B.B. et al. Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology. 2014; 84: 213-216 Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar Factors such as lack of symptoms, being remote from the clinic, lack of time, and unwillingness to undergo another cystoscopy are among the reasons for low follow-up rates. 1 Erickson B.A. Ghareeb G.M. Definition of successful treatment and optimal follow-up after urethral reconstruction for urethral stricture disease. Urol Clin North Am. 2017; 44: 1-9 Abstract Full Text Full Text PDF PubMed Scopus (33) Google Scholar Lack of cystoscopic follow-up in 12 of 35 (34%) patients in our study is in line with this. However, all these patients were interviewed and met the criteria for clinical and functional success as previously described. 2 Erickson B.A. Elliott S.P. Voelzke B.B. et al. Multi-institutional 1-year bulbar urethroplasty outcomes using a standardized prospective cystoscopic follow-up protocol. Urology. 2014; 84: 213-216 Abstract Full Text Full Text PDF PubMed Scopus (60) Google Scholar Although it is known that up to 35% of asymptomatic patients may have strictures at cystoscopy (anatomic failure), the significance of anatomic failure in an asymptomatic and satisfied patient is unknown. This also raises the question if becoming aware of an asymptomatic cystoscopic stricture would negatively affect a patients' conception about success and his satisfaction with the surgery, thereby affecting his quality of life.

Controversies in Obstructive Sleep Apnea Surgery.

Obstructive sleep apnea (OSA) is a common chronic disease characterized by repetitive pharyngeal collapse during sleep. OSA is associated with cardiovascular disease and increased mortality, among other issues. Continuous positive airway pressure (CPAP) is considered first line therapy for OSA, but is not always tolerated. Both non-surgical and surgical alternative management strategies are available for the CPAP intolerant patient. This article explores controversies surrounding airway evaluation, definition of successful treatment, and surgical management of the CPAP intolerant patient with moderate to severe OSA. Controversies specific to maxillomandibular advancement (MMA) are also discussed.

Outcomes of Surgery in Patients with Lumbar Spinal Canal Stenosis: Comparison of Three Types of Stenosis on MRI

The aim of the study was to compare outcome of surgery in patients with lumbar canal stenosis (LCS) based on magnetic resonance imaging (MRI) morphology. This was a prospective study of 96 consecutive patients who underwent surgery at 143 levels of LCS (from L3-L4 to L5-S1). Using patterns on T2 axial MRI, the type of stenosis was determined for each patient. The Swiss Spinal Stenosis Score (SSS) was used to evaluate patients’ functionality and outcomes. The definition of treatment success was based on the criteria developed by Stucki et al. Demographic characteristics and post-operative outcomes were compared between trefoil, triangular, and pin-hole groups. Finally, correlation between SSS score and the MRI morphology was assessed. The mean age of patients was 58.4 (SD = 8.9) years. Post-treatment satisfaction was observed in a large portion of the patients (87.5%). The trefoil group (n = 44), triangular group (n = 38), and pin-hole group (n = 14) had similar pre-operative Swiss Spinal Stenosis Score and were not significantly different in age, operative time, blood loss, duration of symptoms, walking distance, symptom severity and physical function (all p>0.4). No correlation between SSS score and the MRI morphology was observed. The findings suggest that the type of stenosis based on magnetic resonance imaging morphology is not indicative of surgical outcome among lumbar canal stenosis patients who undergo surgery at 1-year follow-up.

Reporting on Outcome Measures of Functional Constipation in Children-A Systematic Review.

Standardized outcome measures provide a basis for comparing outcomes of different clinical trials. Consequently, they can serve as the foundation for determining which therapeutic interventions are most effective. The aim of the present study is to systematically assess how definitions and outcome measures are defined in therapeutic randomized controlled trials (RCTs) of children with functional constipation (FC). PubMed, EMBASE, and Cochrane databases were searched. Studies were included if it was a (systematic review of) therapeutic RCT, concerning children from 1 to 18 years old with FC, a definition of FC was provided, and if they were written in English. The Delphi list was used for quality assessment. A total of 4092 articles were found but only 45 studies fulfilled our inclusion criteria. In these 45 trials, 22 different definitions of FC were used (17 studies used the Rome III-criteria), 27 different interventions were investigated, and 29 different definitions of treatment success were used. Thirty RCTs (57%) reported primary outcomes of which treatment success was the most frequently used. Most trials (80%) used parental diaries of which only 2 RCTs stated that their instrument was validated. Twenty-four trials (53%) were of good methodological quality. Inconsistency and heterogeneity exist in definitions and outcome measures used in RCTs on childhood FC. Standard definitions, outcome measures, and also validated instruments are needed. We recommend the development of a minimum core outcome set for clinical research in children with FC to make comparison possible between the effects of different therapeutic interventions across studies.

Guidelines for the Management of Wet Age-Related Macular Degeneration: Recommendations from a Panel of Greek Experts.

PurposeTo propose guidelines for the management of patients with wet age-related macular degeneration (wAMD), taking into account the results of large multicenter studies and clinical experience of retina experts.MethodA team of retina experts developed a consensus paper after three consecutive meetings. The group was focused on guidelines to help clinical decision-making around the definition of successful treatment and the definition of non-response to therapy.ResultsParameters suggestive of a successful response to treatments included: any gain in best corrected visual acuity (BCVA) or vision loss that is less than 5–10 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, reduction of central retinal thickness, partial or complete absorption of subretinal fluid (SRF), reduction of intraretinal fluid, reduction of pigment epithelial detachment or restoration of the anatomy of outer retinal layers. Non-response to current treatment was considered in the case of loss of BCVA greater than 10 ETDRS letters, increased retinal edema or increase of SRF as evidenced by optical coherence tomography or new bleeding in biomicroscopy.ConclusionThe introduction of anti-VEGF agents revolutionized the treatment of wAMD. Given the complexity of the disease, the emerging new agents and the difference of cases recruited in clinical trials compared to those appearing in every-day practice, it is essential to individualize treatment options taking into account the results of clinical trials.