Standardized Assessment Protocol Research Articles

Scapular fixation in muscular dystrophy

Winging of the scapula is caused by weakness of the thoracoscapular muscles, which allows the scapula to lift off the chest wall during shoulder movements. In facioscapulohumeral muscular dystrophy (and occasionally in other muscular dystrophies) there is selective weakness of the thoracoscapular muscles which may spare other shoulder muscles such as the deltoid muscle. This imbalance results in significant winging and loss of shoulder function. Historically, a number of different surgical and non-surgical interventions have been used to achieve scapular stability. This review examines the evidence available for the use of all scapular fixation techniques in muscular dystrophy, especially facioscapulohumeral muscular dystrophy. To examine the evidence for the relative efficacy of scapular fixation techniques in muscular dystrophy (especially facioscapulohumeral muscular dystrophy) in improving upper limb function. We searched the Cochrane Neuromuscular Disease Group Trials Specialized Register (20 July 2009), The Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2009) Medline (1966 to July 2009) and EMBASE (1980 to July 2009) for randomised trials. We also contacted authors of trials and other experts in the field. All reports of scapular fixation for muscular dystrophy, including quasi-randomised or randomised controlled trials, comparing any form of scapular fixation (surgical and non-surgical) in people (of all ages and of all severity) with scapular winging due to muscular dystrophy. Our primary outcome measure was objective improvement in shoulder abduction. Our secondary outcome measures were: patient-perceived improvement in performance of activities of daily living, cosmetic results, subjective improvement in pain and proportion of patients with significant postoperative complications. We collated and summarised studies on the treatment of scapular winging in muscular dystrophy. No randomised trials were identified. We therefore present a review of the non-randomised literature available. There is no evidence from randomised trials to support the suggestion from observational studies that operative interventions produce significant benefits. However, these have to be balanced against postoperative immobilisation, need for physiotherapy and potential complications. We conclude that a randomised trial would be difficult, but a register of cases and the use of a standardised assessment protocol would allow more accurate comparison of the disparate techniques.

Clinical experience with miglustat therapy in pediatric patients with Niemann–Pick disease type C: A case series

Niemann–Pick disease type C (NP-C) is an inherited neurovisceral lysosomal lipid storage disease characterized by progressive neurological deterioration. Different clinical forms have been defined based on patient age at onset: perinatal, early-infantile (EI), late-infantile (Li), juvenile and adult. We evaluated the efficacy and tolerability of miglustat in 16 symptomatic NP-C patients, with comparative reference to one neurologically asymptomatic, untreated patient. All patients were categorized according to age at neurological disease onset, and were assessed using a standardized clinical assessment protocol: disability and cognitive function scales, positron emission tomography (PET), and biochemical markers. PET and disability scale evaluations indicated that cerebral hypometabolism and neurological symptoms were stabilized during treatment in juvenile-onset NP-C patients. EI and Li NP-C patients, who had higher disease severity at baseline (treatment start), showed increased disability scores and progressive cerebral hypometabolism during follow up. Similarly, while cognitive scale scores remained relatively stable in patients with juvenile NP-C, cognition deteriorated in EI and Li patients. Plasma chitotriosidase (ChT) activity was lower in the juvenile NP-C subgroup than in EI and Li patients, and generally increased in patients who discontinued treatment. Plasma CCL18/PARC and ChT activities indicated greater macrophagic activity in EI and Li patients versus juveniles. Miglustat was generally well tolerated; frequent adverse events included diarrhea and flatulence, which were managed effectively by dietary modification and loperamide. Overall, miglustat appeared to stabilize neurological status in juvenile-onset NP-C patients, but therapeutic benefits appeared smaller among younger patients who were at a more advanced stage of disease at baseline.

The Utility of Lumbar Paraspinal Mapping in the Diagnosis of Lumbar Spinal Stenosis

The aim of this prospective, blinded and controlled study is to evaluate the utility of lumbar paraspinal mapping in the diagnosis of lumbar spinal stenosis. The subjects were assessed and allocated into three groups according to clinical and radiologic features with a standardized assessment protocol. These three groups were clinical and radiologic lumbar spinal stenosis, radiologic lumbar spinal stenosis, and the control group. The measurements of magnetic resonance imaging studies were performed by a blinded radiologist. An electromyographer who was masked to patients' data performed all the nerve conduction tests, lower-limb needle electromyography, and lumbar paraspinal mapping. The relations of clinical, radiologic, and electrophysiologic findings were investigated. Sixty-two patients were enrolled in the study. Two patients were eliminated because electrophysiologic studies showed polyneuropathy. There were 28, 16, and 16 patients in clinical and radiologic lumbar spinal stenosis, radiologic lumbar spinal stenosis, and control groups, respectively. In the clinical and radiologic lumbar spinal stenosis group, the findings of limb needle electromyography were inconsistent with 50% acute and 46.4% chronic radiculopathy. However, the paraspinal mapping showed that there were fibrillation potentials and positive sharp waves in at least two levels in 92.8% of the patients in clinical and radiologic lumbar spinal stenosis. The mean total paraspinal mapping score was 33.64 ± 21.17, which was significantly higher than the radiologic lumbar spinal stenosis and control groups. In the radiologic lumbar spinal stenosis group, the findings of paraspinal mapping were normal in 93.8% of the patients. Paraspinal mapping technique was found to be better correlated to the clinical findings than magnetic resonance imaging in asymptomatic patients. In the control group, 6 of 14 patients had high total paraspinal mapping scores (range, 0-9). Those patients with higher paraspinal mapping scores in the control group were mostly diagnosed with acute monoradiculopathy caused by disc herniation. Paraspinal mapping technique is a sensitive method in the diagnosis of lumbar spinal stenosis and reflects physiology of nerve roots better than the limb electromyography.

Outcomes Measures Used to Assess Results After Surgery for Cubital Tunnel Syndrome: A Systematic Review of the Literature

The primary objective of this systematic review was to identify and analyze the outcomes measures that have been used to evaluate postoperative results following surgery for cubital tunnel syndrome. The secondary objective was to compare the postoperative results among patients evaluated using patient-satisfaction instruments to those evaluated using surgeon-reported scales. Computerized database searches of MEDLINE, EMBASE, and MEDLINE In-Process were performed. Studies involving adults with cubital tunnel syndrome in whom the surgical intervention was simple decompression, anterior transposition (subcutaneous, submuscular or intramuscular), endoscopic decompression, or medial epicondylectomy were included. A systematic review was performed that included randomized controlled trials, comparative observational studies, noncomparative observational studies, and case series. This systematic review of the literature identified 42 studies that satisfied the inclusion criteria. The authors identified 21 health outcomes measures used in cubital tunnel studies. These consisted of 2 generic instruments; 10 symptom-specific, author-reported instruments; 3 symptom-specific, patient-reported instruments; and 6 patient questionnaires. No measure demonstrated adequate development or validation for use in its target population. Available data revealed a consistently high level of patient satisfaction following simple decompression or submuscular transposition (65% to 92%). The results of the author-reported, symptom-specific scales varied widely and showed no obvious association with patient satisfaction. The variation in reporting of results prevented statistical comparisons between author-reported results and patient-reported results. To the best of our knowledge, this is the first systematic review to delineate the outcomes measures used to evaluate the treatment of cubital tunnel syndrome. Our results show that reliable, reproducible, and valid outcomes measures are lacking from the surgical literature. A standardized assessment protocol for ulnar neuropathy is required for future comparison trials. Therapeutic III.

Nurses' positive attitudes to nutritional management but limited knowledge of nutritional assessment in Korea

Nurses' involvement in nutritional management has received greater emphasis as an accountable factor for the nutritional status of patients. Studies have shown that there are deficiencies in awareness of the importance of nutritional assessment and limited nutritional knowledge in nurses. The purpose of this study was to investigate nutritional attitudes and knowledge of nurses working in the hospital environment. A questionnaire survey was conducted. It is focused on nutritional management with regard to assessment of nutritional status and implementation of nutritional care. Nurses were recruited from the university hospital in Seoul, Korea. A majority of nurses had positive attitudes towards patients' nutritional status and had a high desire to receive nutritional information. However, they had limited knowledge of nutrition, especially nutritional assessment criteria which are basic to the evaluation of patient's nutritional status. Nurses did not perform the nutritional assessment appropriately in practice. These findings suggest that nurses have limited nutritional knowledge and they use nutritional assessment criteria poorly in clinical settings. This study provides a framework for developing nutritional management programmes and a standardized protocol for nutritional assessment.

A Summary of Preclinical Topical Microbicide Rectal Safety and Efficacy Evaluations in a Pigtailed Macaque Model

There is widespread recognition of the potential promise of vaginal microbicides as a tool to combat global human immunodeficiency virus/acquired immunodeficiency syndrome and sexually transmitted infections epidemics, and candidate product development has maintained a rapid pace in recent years; however, rectal microbicide development has received less attention. As it is likely that commercial products developed for vaginal use will also be used rectally, there is a clear need to assess the safety and efficacy of candidate microbicide products specifically in the rectal compartment. We have developed a standardized protocol for preclinical rectal safety and (chlamydial) efficacy assessment of topical microbicide candidates in a nonhuman primate model. We evaluated a total of 12 test compounds for rectal safety (via rectal pH, microflora, and rectal lavage) and 1 compound for efficacy against rectal chlamydial infection. In this article, we describe our methods in detail and summarize our results, particularly noting the ability of our model to distinguish products with deleterious effects on the rectal environment. We also outline the specific criteria used to recommend products move into preclinical rectal efficacy trials or be recommended for reformulation to the product developer. In summary, we observed significant adverse effects in 2 products. The single product that underwent efficacy evaluation was not observed to be protective against rectal chlamydial infection. A preclinical safety and efficacy model is critical to promoting rectal microbicide development, which will ultimately offer a significant opportunity for intervention in the global HIV/AIDS epidemic.

Food For Thought: Self-Criticism and Raising the Bar of Dysphagia Practice

AbstractThe assessment and treatment of swallowing disorders have become central to the practice of the medical speech-language pathologist. The outcomes associated with swallowing and swallowing disorders are severe with aspiration pneumonia, malnutrition and dehydration, and reduced quality of life among the most concerning. Clinicians practicing in this area possess unequal skills, training, and experience, and there is considerable variation in practice in the field. This article focuses on variation and error in swallowing assessment with attention to reliability and accuracy of the videofluoroscopic swallowing assessment. In this self-critical overview of the practice, recommendations are made for developing a standardized assessment protocol, shared lexicon, and specialty recognition in the area of swallowing and swallowing disorders.

Establishing Best Practice in Pediatric Emergency Mental Health

The objectives of this prospective study were to determine the demographic and clinical characteristics of children and youth presenting to the emergency department (ED) for mental health concerns through the use of a valid standardized assessment protocol. Children and adolescents, 8 to 17 years, who presented to an ED-based crisis intervention program during fiscal years 2005 to 2006, completed self-report measures of depression, anxiety, and behavior. Clinicians completed the childhood acuity of psychiatric illness based on their assessment. The clinician ratings indicated that 93.1% of the sample had at least 1 risk behavior or clinical symptom in the moderate/severe range. Admittance rate for the sample was 17.9% (low-risk admissions, 5.8%; high-risk deflections, 9%). Significant differences were found in presentations by sex and age as follows: (1) female youths (12-17 years) were more likely than male youth to report clinically significant depressive symptoms and to present with suicidal ideation/gesture and self-injury. (2) Male youths (12-17 years) were more likely to present with aggression to people/objects than female youth. (3) Male children younger than 12 years were more likely to present with high activity level than female children. Self-report measures (depression, anxiety, and behavior) corelated with corresponding clinician ratings. This research, through the use of a multi-informant standardized assessment protocol, presents a comprehensive study of children and youth presenting to the ED with mental health issues. Identifying the clinical characteristics of this population is an important first step toward establishing best practice within an ED.

Symptom Prevalence of ADHD in a Community Residential Substance Abuse Treatment Program

Objective: ADHD is a common comorbid condition with substance use disorder. This study seeks to examine the discrepancy in the prevalence rate between those previously diagnosed with ADHD and those diagnosed while in treatment. It is hypothesized that clients with ADHD would have earlier unsuccessful terminations from treatment than non-ADHD clients and that the ADHD Self-Report Scale (ASRS Version 1.1) would be a reliable predictor. Method: Participants (N = 87) are admitted to a publicly funded 28-day residential treatment program. All participants are screened with the ASRS and participate in a clinical assessment evaluation. Results: A significant difference is found between the clinical record rate of 3.44% and the 43.68% rate found during treatment. The ASRS significantly predicts ADHD. Conclusions: The use of the ASRS is recommended and should be incorporated into standard intake assessment protocols. Careful diagnostic interviews are urged to determine if clients in residential treatment have ADHD.

Employment status amongst those with psychosis at first presentation

Employment is generally beneficial to health and quality of life. Despite many advances in the treatment of psychosis there are continuing reports of high levels of unemployment. In most studies of first episode psychosis (FEP) only rudimentary rates of employment are provided. We sought to establish the prevalence of employment amongst those with FEP from a geographically defined area, to compare employment categories for differences in demographical and clinical characteristics and finally, to examine factors associated with employment. All cases of FEP were assessed from a defined suburban area with a structured clinical interview for DSM-III-R diagnosis and a standardised assessment protocol. Employment status was divided into employed, non-labour force work and unemployed. Of 162 cases of psychosis, those employed (46%) were indistinguishable from those in non-labour force work (21%). Those unemployed (33%) had significantly longer DUP, more negative symptoms and lower quality of life than those engaged in non-labour force work or those employed. Having a non-affective psychosis (chi(2) = 0.05, OR = 1.2; 95% CI 1.0, 1.4) was associated with being unemployed at presentation. Better (beta = -0.2, P = 0.00) academic premorbid adjustment was associated with being employed at presentation. Although 67% of those with FEP from a geographically defined area are engaged in purposeful work, the rate of unemployment is nine times the local rate. Longer DUP and negative symptoms are associated with unemployment at presentation. Standardised reporting of employment status would greatly assist research in this area.

How do we evaluate sentinel nodes and interpret the findings?

Sentinel lymph node (SLN) biopsy has become standard care for axillary lymph node staging, allowing routine, pathologic SLN examination by serial sections (SS) and/or immunohistochemical (IHC) stains. Although these methods increase the accuracy of staging, the prognostic significance of SLN micrometastases (pN0i+ [< 0.2 mm] and pN1mi [0.2–2 mm]), and especially of those detected only by IHC, is controversial. Retrospective studies have addressed this issue by relating survival to size of nodal metastasis, or by using SS and/or IHC to reassess nodes initially staged as negative, and suggest but do not conclusively prove that SLN micrometastases are associated with a modest decrement in overall and/or disease-free survival. Because there is no current standardized protocol for the pathologic assessment of SLN, prospective trials in progress will establish whether SS and/or IHC are worthwhile.

Requirement profile for police interview assistance dogs

behavioral assessment protocols and, second, to develop a standardized and scientifically-validated protocol to assess the adoption suitability of Australian shelter dogs. The first part of this research comprised a literature review, personal observations of over 50 assessments, and interviews with 26 shelter workers involved directly in assessing dogs. The results of these analyzes were used to develop a standardized shelter dog assessment protocol called the Behavioral Assessment for Re-homing K9s (B.A.R.K.). The second part of the research is underway currently and involves implementation of the B.A.R.K. protocol into several Australian animal shelters for evaluation of its acceptability and ease of use, test–retest and inter-rater reliability, as well as concurrent and predictive validity. As anticipated, based on previous reports, the review showed a lack of standardization in content and methodology in the protocols used to assess canine behavior to determine adoption suitability; e.g., the duration of assessment protocols ranged from 5 to 40 minutes (mean 5 24 minutes, SD 5 12 minutes), assessor experience ranged from 6 months to 16 years (mean 5 2.5 years, SD 5 3.3 years) and many lacked confidence that their existing protocol was the most appropriate one to use and in their own ability to accurately assess dogs in shelters. Experience was not correlated significantly with confidence in the existing protocol (r 520.37, n 5 26, P . 0.05) or with confidence in their ability to accurately assess shelter dogs (r520.19, n5 26, P. 0.05). The majority (85%) of assessors thought their current protocol could be improved. All 26 assessors (100%) agreed that a standardized and scientifically validated assessment protocol would be beneficial. Accordingly, uptake of the B.A.R.K. protocol has been strong and preliminary data from the implementation stage of the project are promising. These findings show that there is an immediate need for a standardized and scientifically-validated protocol to assess behavior and adoption suitability in shelter dogs.

Living liver donor death related to complications of myeloma

We report a donor death after right hepatectomy for living donor transplantation due to an undiagnosed myeloma. The 47-year-old donor, who was the 147th case performed in our department, was in excellent health without any abnormalities in the preoperative investigations. Despite an uneventful right hepatectomy without transfusion, the patient developed a partial thrombus of the inferior vena cava with a right proximal pulmonary trunk embolism on postoperative day 6. Subsequently, he developed multiorgan dysfunction leading to a coagulopathy, respiratory distress, and renal failure requiring hemodialysis and mechanical ventilation. This clinical scenario led us to suspect a hematological disorder. Immune electrophoresis showed a monoclonal peak of immunoglobulin G (8.7 g/L), a myelogram revealed an abnormally high level of dystrophic plasmocytes (more than 7%), and biopsies of salivary glands confirmed the diagnosis of immunoglobulin G kappa myeloma. The patient progressively deteriorated because of simultaneous hemorrhagic and infectious pulmonary complications resulting in septic shock. Despite an adequate combination of antimicrobial therapy and pleural drainage, the donor died on postoperative day 57 from multiple organ failure. This unusual cause of donor death after right hepatectomy reinforces the need for an extensive preoperative assessment. We advocate the addition of urinary protein loss and electrophoresis to the standard donor assessment protocol.

Establishment of the pipeline for RNA quality assessment from the cells obtained by laser capture microdissection

We developed a standard protocol for quality assessment of low amount RNA from the cells obtained by laser capture microdissection (LCM). Three gastric noncancerous tissues were cryo-sectioned, stained with Cresyl Violet, and pathologically rechecked. Epithelial cells were obtained by LCM and RNA was isolated. Agilent 2100 bioanalyzer was used to check the RNA quality. To validate the results from 2100 bioanalyzer, RT-PCR was performed with six genes at both 5'and 3' end-regions of different abundance (EF1A and ATCB of high abundance, GAPDH and B2M of moderate abundance, and MED1 and CK20 of low abundance). RT-PCR analysis of 3 good quality RNAs from cultured cell lines and 3 poor quality RNAs from gastric noncancerous tissues showed high correlations with that from 2100 bioanalyzer. In conclusion, the pipeline for low amount RNA quality assessment by RT-PCR from tissue cryo-section, pathological recheck, LCM purification and RNA isolation is applicable as a routine method in cancer genome research.

Stopping to Rest During a 400‐Meter Walk and Incident Mobility Disability in Older Persons with Functional Limitations

To examine the association between stopping to rest during a 400-m usual-pace walk test (400-MWT) and incident mobility disability in older persons with functional limitations. Prospective cohort study. Community based. Four hundred twenty-four participants in the Lifestyle Intervention and Independence for Elders Pilot (LIFE-P) Study aged 70 to 89 with functional limitations (summary score < or =9 on the Short Physical Performance Battery (SPPB)) but able to complete the 400-MWT within 15 minutes. Rest stops during the 400-MWT were recorded. The onset of mobility disability, defined as being unable to complete the 400-MWT or taking more than 15 minutes to do so, was recorded at Months 6 and 12. Fifty-four (12.7%) participants rested during the 400-MWT at baseline, of whom 37.7% experienced mobility disability during follow-up, versus 8.6% of those not stopping to rest. Performing any rest stop was strongly associated with incident mobility disability at follow-up (odds ratio (OR)=5.4, 95% confidence interval (CI)=2.7-10.9) after adjustment for age, sex, and clinic site. This association was weaker, but remained statistically significant, after further adjusting for SPPB and time to complete the 400-MWT simultaneously (OR=2.6, 95% CI=1.2-5.9). Stopping to rest during the 400-MWT is strongly associated with incident mobility disability in nondisabled older persons with functional limitations. Given the prognostic value, rest stops should be recorded as part of the standard assessment protocol for the 400-MWT.

Identifying Patients in Financial Need

Some eligible patients with financial hardship may not be referred to assistance programs because cancer care providers do not know the full extent of patients' needs. This article describes barriers cancer care providers face in identifying patients who have financial concerns by using qualitative data from 21 interviews with providers from one Canadian province. Interviews were audio recorded, transcribed verbatim, and analyzed with a thematic approach. Four major themes emerged: no standardized approach existed for assessing needs, family members rather than patients may have better awareness of financial concerns, patients may not be forthcoming about financial concerns, and financial concerns may change over time. Adopting a standardized assessment protocol that routinely screens patients at multiple times during their care, educating patients about out-of-pocket costs, and educating providers to identify and assess financial need may enable more patients to access available financial resources. Although the Canadian and U.S. healthcare systems are different, concerns about out-of-pocket costs may be similar.

Development of Clinical Ratings for Crisis Assessment In Community Mental Health

Few measurements have been developed to aid clinicians in mental health crisis assessment. Authors developed clinical dimensions from both experienced, licensed professionals working in crisis and salient characteristics of individuals presented to a crisis service located in a community mental health center. Five criteria, combined with a standard assessment protocol, were rated by 15 licensed professionals. These five criteria were tested as plausible dimensions for future measurement development. Clinical ratings by licensed professionals on 618 episodes of crisis over an 18-month period were analyzed to determine the latent structure and predictive potential of triage dispositions. The five criteria and a composite total were predictive of differential triage dispositions. An exploratory factor analysis indicated a two-factormodel, whichwe termed ‘‘self-destructive mood’’ and ‘‘perturbation.’’ Future development of thismodel and future refinement of this measure are discussed. [Brief Treatment and Crisis Intervention 8:304–312 (2009)]

A Summary of Preclinical Topical Microbicide Vaginal Safety and Chlamydial Efficacy Evaluations in a Pigtailed Macaque Model

The development of topical microbicides represents a new and exciting field in the prevention of sexually transmitted diseases, and it is especially important that candidate products undergo rigorous preclinical safety and efficacy testing before advancing to clinical trials. We have developed a standardized protocol for preclinical vaginal safety and efficacy assessment of topical microbicide candidates in a nonhuman primate model. Over 7 years of funding under an NIH contract, we evaluated a total of 28 test compounds for vaginal safety (via colposcopy, vaginal pH, and microflora) and 9 compounds for efficacy against cervical chlamydial infection. In this article, we describe our methods in detail and summarize our results, particularly noting the ability of our model to distinguish products with deleterious effects on the cervicovaginal environment. We also outline the specific criteria used to determine which products should move into efficacy trials and which should be recommended for reformulation to the manufacturer. Overall, we noted acceptable safety profiles for 24 of 28 candidate products. Common findings included a transient decrease in vaginal pH, petechiae, and mild erythema. Four products were associated with significant adverse colposcopic findings including blisters, epithelial abrasions, and friability; all 4 products were successfully reformulated and showed acceptable safety profiles at lower concentrations. No products showed complete protection against cervical chlamydial infection. The macaque preclinical safety and efficacy model is critical to maintaining the pace of topical microbicide development, which could ultimately offer a significant opportunity for intervention in the global HIV/AIDS epidemic.

Animal welfare as a pillar of a sustainable farm animal production

Despite research and legislation carried out in the last decades, we are still in progress to fulfil the public concerns about the definition of sustainable production standards as regards the welfare of farm animals. The assessment of animal welfare on-farm is nowadays one of the outstanding issues for several reasons: 1) identify risk factors still present at the farm level for livestock welfare, 2) find solutions to overcome welfare problems, 3) define minimum requirements for all the farm animals species and categories or refine the exiting recommendations, 4) create certification schemes for labelling welfare friendly farm animal products. Ideally a standardized welfare assessment protocol should be based on a multidisciplinary approach but, for feasibility reasons, most of the proposed monitoring schemes have been based mainly on the evaluation of farm housing and facilities. The Welfare Quality® research consortium is currently working on a new assessment tool largely based on valid and reliable measures recorded by clinical and behavioural observation of the animals. Differing from the existing protocols for animal welfare assessment, the Welfare Quality® scheme aims to be a valuable support to farmers and the animal industry in their efforts to improve the welfare status of farm animals. Therefore the system shall provide a feedback of information on how to improve welfare along the productive chain of farm animals. The routine application of this type of assessment schemes appears an effective tool to promote a general improvement of the quality of life of farm animals as well as to address the consumer choices towards welfare friendly animal foodstuffs.

The effect of media pH on embryo development and cycle outcome

OBJECTIVE: There has been debate on the optimal embryo culture conditions during in vitro fertilization cycles. This study was undertaken to determine the effect of media pH on embryo quality, the development of early cleaving embryos, and cycle outcome. DESIGN: Prospective, non-randomized study. MATERIALS AND METHODS: Fifteen patients with a minimum of 15 oocytes at retrieval were included in the study. Study patients had their oocytes split between a test incubator with an increased CO2 concentration and a control incubator set at a standard CO2 level. This study design allowed for the patient to act as their own control group. The oocytes from both incubators were observed for fertilization, the presence of early cleaving embryos, and Day 3 development at set hours. The embryos were graded using a standard morphology assessment protocol in order to choose the best quality embryos for Day 3 transfer regardless of which incubator was used for culture. Embryos that were of good quality and not chosen for transfer were subsequently frozen on Day 3. Patients were monitored post transfer and a positive pregnancy defined as the presence of an intrauterine sac. Data were analyzed using the unpaired t-test and the Fisher's exact test, with significance set at P < 0.05. RESULTS: The average pH values of the test and control incubators were significantly different (7.30 vs. 7.38, p < 0.0001). The lowered pH did result in a significantly higher number of blastomeres on Day 3 (7.11 vs. 6.25, p = 0.025). In addition, a higher percentage of embryos transferred were derived from the test incubator (22.0% vs. 10.7%, p = 0.045). While there was a trend towards an increased percentage of early cleaving embryos from the test incubator (22.0% vs. 17.2%) the difference was not significant (p = 0.08). There was no difference in the fertilization rate, embryo fragmentation rate, the development of embryos to at least the five cell stage on Day 3, or the percentage of frozen and discarded embryos. Nine cycles were examined where all of the transferred embryos came from exclusively one incubator. The clinical pregnancy rate was determined to be identical in these two groups (33.3%). CONCLUSIONS: This study demonstrated the role that media pH has on embryo quality as assessed by standard morphological criteria. Ongoing studies are being performed to further establish the effect of decreased media pH on clinical outcomes.