Psychometric Validation of the Perception of Injection (PIN) Questionnaire Using Data From Two Phase III, Open-Label, Active-Controlled, Non-Inferiority Studies in People Living With HIV.

INTRODUCTION: Currently, there are no patient-reported outcome tools specifically validated for use in people living with human immunodeficiency virus (PLHIV) to measure treatment injection acceptance and experience. The Perception of Injection (PIN) questionnaire was modified with consent from the Vaccinees' Perception of Injection (VAPI), a validated instrument developed by Sanofi Pasteur. The objective of developing the PIN was to provide information on participant experience with injectable therapies, including acceptance of pain, injection-site reactions, and tolerability following injections in PLHIV. METHODS: This post hoc analysis used data from participants who received the long-acting intramuscular cabotegravir plus rilpivirine combination treatment every 4 weeks, as part of the ATLAS (NCT02951052) and FLAIR (NCT02938520) studies, to evaluate the psychometric properties of the PIN questionnaire. RESULTS: These findings support the reliability, validity, and responsiveness to change for the PIN questionnaire in PLHIV. CONCLUSION: As a clinical trial endpoint, the PIN questionnaire could provide valuable evidence around the acceptance and experience of injections in PLHIV which could have implications for treatment adherence in this population. TRIAL REGISTRATION: ATLAS (NCT02951052); 1 November, 2016. FLAIR (NCT02938520); 19 October, 2016.

Comparative efficacy and tolerability of pharmacological and somatic interventions in adult patients with treatment-resistant depression: a systematic review and network meta-analysis.

OBJECTIVE: Major depressive disorder (MDD) affects about 10-15% of the general population in a lifetime. A considerable number of patients fail to achieve full symptom remission despite adequate treatment and are considered treatment resistant (TRD). The current study compared the relative efficacy and tolerability of pharmacological and somatic TRD interventions by means of a Bayesian network meta-analysis. RESEARCH DESIGN AND METHODS: An electronic literature search of MEDLINE, MEDLINE In-Process, EMBASE, PsycInfo, EconLit and Cochrane Library databases for trials published between September 2003 and September 2014 was conducted. Key outcomes extracted were disease severity change from baseline, response and remission rates at various timepoints and discontinuation due to adverse events. RESULTS: Of the 3876 abstracts identified, 31 publications/randomised controlled trials (RCTs) were included in the analysis; 19 RCTs investigating 13 pharmacological interventions and 12 RCTs investigating electroconvulsive therapy (ECT) and repetitive transcranial magnetic stimulation (rTMS). The evidence synthesis investigating efficacy outcomes of TRD treatments demonstrated superior efficacy for ketamine compared to pharmacological and somatic interventions at 2 weeks after treatment initiation. At 4, 6 and 8 weeks, quetiapine augmentation (800 mg/day) and risperidone augmentation were found to be the first and second best treatments, respectively. Networks were small for response rate and remission rate outcomes at most timepoints. The most tolerable treatment was lamotrigine augmentation showing a comparable profile to placebo/sham. CONCLUSIONS: This analysis revealed scarcity of long-term data on sustained remission that would allow a comparative long-term efficacy assessment. Key limitations of the analysis can be considered the search timeframe and the use of mapping formula for the depression scores.

Visual acuity improvements after implantation of toric intraocular lenses in cataract patients with astigmatism: a systematic review.

BACKGROUND: Cataracts are a common and significant cause of visual impairment globally. We aimed to evaluate uncorrected distance visual acuity (UDVA) as an outcome in treating astigmatic cataract patients to assist clinicians or ophthalmologists in their decision making process regarding available interventions. METHODS: Medline, Embase and Evidence Based Reviews were systematically reviewed to identify relevant studies reporting changes in UDVA, UIVA and UNVA after cataract surgery in presbyopic patients. Strict inclusion/exclusion criteria were used to exclude any non-relevant studies. Relevant outcomes (UDVA, UIVA and UNVA) were identified from the studies retrieved through the systematic review process. RESULTS: The systematic review identified 11 studies which reported UCVA. All 11 studies reported UDVA. Four brands of toric intraocular lenses (IOLs) were reported in these studies. All studies identified in the literature search reported improvements in UDVA following surgical implant of a toric IOL. The largest improvements in VA were reported using the Human Optics MicroSil toric IOL (0.74 LogMAR, UDVA) and the smallest improvements were also reported using the Human Optics MicroSil toric IOL (0.23 LogMAR, UDVA) in a different study. CONCLUSIONS: The results of this systematic review showed the aggregate of studies reporting a beneficial increase in UDVA with the use of toric IOLs in cataract patients with astigmatism.

Distance and near visual acuity improvement after implantation of multifocal intraocular lenses in cataract patients with presbyopia: a systematic review.

PURPOSE: To evaluate uncorrected distance visual acuity (UDVA) as well as uncorrected near visual acuity (UNVA) as outcomes in treating presbyopic cataract patients to assist clinicians and ophthalmologists in their decision-making process regarding available interventions. METHODS: Medline, Embase, and Evidence Based Medicine Reviews were systematically reviewed to identify studies reporting changes in UDVA and UNVA after cataract surgery in presbyopic patients. Strict inclusion/exclusion criteria were used to exclude any studies not reporting uncorrected visual acuity in a presbyopic population with cataracts implanted with multifocal intraocular lenses (IOLs). Relevant outcomes (UDVA and UNVA) were identified from the studies retrieved through the systematic review process. RESULTS: Twenty-nine studies were identified that reported uncorrected visual acuities, including one study that reported uncorrected intermediate visual acuity. Nine brands of multifocal IOLs were identified in the search. All studies identified in the literature search reported improvements in UDVA and UNVA following multifocal IOL implantation. The largest improvements in visual acuity were reported using the Rayner M-Flex lens (Rayner Intraocular Lenses Ltd) (UDVA, binocular: 1.05 logMAR, monocular: 0.92 logMAR; UNVA, binocular and monocular: 0.83 logMAR) and the smallest improvements were reported using the Acri.LISA lens (Carl Zeiss Meditec) (UDVA, 0.21 decimal; UNVA, 0.51 decimal). CONCLUSIONS: The results of this systematic review show the aggregate of studies reporting a beneficial increase in UDVA and UNVA with the use of multifocal IOLs in cataract patients with presbyopia, hence providing evidence to support the hypothesis that multifocal IOLs increase UDVA and UNVA in cataract patients.

Patient perspectives on taking vitamin K antagonists: a qualitative study in the UK, USA and Spain.

AIM: Limitations of vitamin K antagonists (VKAs) include frequent monitoring, dietary restrictions and drug interactions. This study conducted an indepth exploration of perspectives of VKA therapy in respondents with atrial fibrillation or venous thromboembolism. METHODS: A total of 60 respondents, recruited from the UK, USA and Spain, were interviewed on their experiences and views of VKA therapy. Thematic analysis was conducted on the data. RESULTS: Although there were some differences between the countries and some small differences between atrial fibrillation and venous thromboembolism respondents, many respondents found various aspects of VKA to be burdensome, including the international normalized ratio monitoring and dietary considerations. CONCLUSION: Atrial fibrillation and venous thromboembolism respondents accept the limitations of VKAs and the adjustments to their lifestyles, but recognize a lack of alternative treatment.

Psychometric evaluation of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS).

In this study we developed and evaluated the psychometric properties of the Satisfaction with Oral Anti-Diabetic Agent Scale (SOADAS), the first treatment satisfaction instrument specific to oral anti-diabetic agents (OADs). Three focus groups and three rounds of cognitive debriefing interviews with type 2 diabetes patients using OADs informed the development of the six-item SOADAS. The measurement properties of the SOADAS were evaluated in a US cross-sectional study. Patients completed the SOADAS, Treatment Satisfaction for Medication Questionnaire (TSQM), the Short Form-12 (SF-12) Health Survey and a demographic questionnaire. The first half of the recruited patient population was asked to return at 7 days follow-up to complete the SOADAS again. An exploratory factor analysis on the SOADAS yielded a one-factor solution, indicating that the SOADAS was uni-dimensional. The SOADAS had high internal consistency reliability (Cronbach's alpha=0.86) and acceptable test-retest reliability (ICC=0.79). It was correlated most highly with the TSQM (r=0.71, p<0.001) and least with the mental summary component score of the SF-12 (r=0.24, p=0.014). Mean SOADAS scores were approximately two points higher for participants with lower HbA(1c) values (<7%) versus those with higher values, and for participants without versus with selected symptoms (p<0.05). The findings from this study suggest that the SOADAS is a valid and reliable measure of patient satisfaction with oral anti-diabetic medications. This questionnaire may be useful for assessing outcomes in future clinical studies of oral anti-diabetic medications.