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PubMed2005

New insulin infusion protocol Improves blood glucose control in hospitalized patients without increasing hypoglycemia.

BACKGROUND: Aggressive treatment of hyperglycemia in hospitalized patients can improve clinically important outcomes. At the University of Washington Medical Center a quality improvement project was conducted to develop and implement a standardized insulin infusion protocol for use throughout the institution. METHODS: The insulin infusion protocol was piloted on critical and non-critical care inpatient units. Safety and efficacy data were collected for a one-month period on each unit. RESULTS: A total of 156 patients were evaluated. The incidence of hypoglycemia was lower for the study group than the historical controls, as was the mean percentage of time patients were hyperglycemic, 15% +/- 2.3% vs. 33% +/- 2.6% for the critical care subgroup (p < .0001) and 18% +/- 2.4% vs. 56% +/- 2.3% for the non-critical care subgroup (p < .0001). CONCLUSIONS: The insulin infusion protocol better met the insulin requirements of our patients and achieved better glycemic control than previous protocols at the institution. In addition, there was no increase in hypoglycemia despite the use of the protocol in non-critical care units with higher patient-to-nurse ratios, suggests that insulin infusion therapy can be safely used outside of critical care units.

Blood Glucose↗

PubMed2002

The identification of barriers preventing the successful implementation of a surgical prophylaxis protocol.

AIM: The aim of this study was to introduce a protocol for the use of antimicrobials in surgical prophylaxis for the described procedures in Antrim Area Hospital. METHOD: Historical data of antimicrobial use were obtained from retrospective analysis of patients' charts, for those patients identified as having one of the following 'clean/contaminated' surgical procedures over the previous six months; cholecystectomy or abdominal hysterectomy. These data were analysed, and a protocol was introduced providing guidelines for the choice of antimicrobial agent, its administration time, route, dose, duration and frequency of treatment. MAIN OUTCOME MEASURE: The main outcome measure was the success of the uptake of the protocol following its implementation. RESULTS: There was a total of 285 patients identified, 105 prior to and 180 post implementation. Overall, 68% of patients received some form of prophylaxis in the first cycle, and 72% in the second. CONCLUSION: Although the introduction of the protocol led to slight improvements in compliance with standard prescribing procedures, with an increase in single-dose prophylaxis, and a reduction in prolonged prophylactic treatment, the improvements did not reach expectations. This paper attempts to identify the possible barriers to protocol implementation.

Antibiotic Prophylaxis↗

PubMed2003

Clinicopathological evaluation of renal allografts of four patients by 20-year protocol biopsies.

Twenty-year protocol biopsies were performed in four cases of renal transplant recipients with grafts that had survived 20 years or more. All four recipients received transplants from their parents, and never had episodes of acute rejection. They were maintained with the conventional immunosuppressive protocol including azathioprine, mizoribine, and prednisolone. Three of them had past history of malignant diseases such as breast cancer and tongue cancer. In spite of fair graft function, the microscopic findings of 20-year protocol biopsy showed various degrees of histological damage; e.g. obsolescence of the glomeruli, glomerulosclerosis, arteriole wall thickening, interstitial fibrosis and tubular atrophy. Although two of the four grafts were functioning with low serum creatinine levels (1.3-1.4 mg dL-1) at 24 years and 26 years following transplantation, respectively, the function of the other two grafts had decreased more than 20 years after transplantation. In the two grafts with decreased function, glomerulosclerosis and arteriole wall thickening tended to be more severe (Banff classification of chronic allograft nephropathy [CAN] grade II and III) at the 20-year protocol biopsy compared with the two well-functioning grafts (CAN grade I and II). We conclude that the protocol biopsies even at 20 years can contribute to predict the fate of renal allografts.

Adolescent↗

PubMed2006

Neonatal illicit drug screening practices in Iowa: the impact of utilization of a structured screening protocol.

OBJECTIVE: The purpose of the study was to determine the neonatal illicit drug screening practices of Iowa birthing hospitals. STUDY DESIGN: Cross-sectional survey design was implemented. The impact of structured screening protocols on the numbers of neonates screened and positive testing in 2004 was reviewed. RESULTS: Of 81 birthing hospitals, 53 (65%) participated in the study. Screening and positive test rates were higher in hospitals utilizing a structured screening protocol compared to those not utilizing one (10.9 versus 2.1% and 0.9 versus 0.2%, respectively, P < 0.0001). Hospitals with higher population, numbers of outpatients, inpatients, deliveries, and availability of drug abuse treatment services utilized a structured screening protocol more often. CONCLUSION: Utilization of a structured screening protocol increases the number of neonates screened for illicit drugs and positive testing rate regardless of urbanization. Regional standardization of structured screening protocols may improve the recognition of perinatal illicit drug exposure and provision of treatment services.

Clinical Protocols↗

PubMed2000

Long-term follow-up of Dutch Childhood Leukemia Study Group (DCLSG) protocols for children with acute lymphoblastic leukemia, 1984-1991.

Here we report the long-term results of the DCLSG protocols ALL-6 and -7 with special emphasis on the incidence of CNS relapse after treatment without cranial irradiation. In DCLSG protocol ALL-6 (1984-1988), designed for patients with ALL non-high risk (ALL-NHR) (WBC <50 x 10(9)/l, no mediastinal mass, no B cell phenotype and no CNS involvement at diagnosis, comprising 71% of all ALL patients), CNS prophylaxis consisted of a combination of three methods of chemotherapeutic CNS prophylaxis (the use of dexamethasone during induction and maintenance therapy, i.v. medium dose methotrexate and prolonged administration of intrathecal triple therapy). Total duration of treatment: 116 weeks. 190 patients were enrolled in the study. At 10 years, the EFS rate for all patients is 81.5 +/- 2.8%, the survival rate 84.8 +/- 2.7%, and the cumulative incidence of isolated CNS relapse 1.1 +/- 0.8%. The 10-year survival rate for the 139/190 (73.1%) patients with standard risk non-T lineage ALL according to the NCI risk criteria is 80.5 +/- 3.4%. DCLSG protocol-7 was identical to the intensive ALL-BFM-86 protocol, but cranial irradiation was restricted to patients with initial CNS involvement. Patients were stratified into three risk groups (SRG, RG and EG). Treatment duration was 18 months. 218 patients were enrolled in the study. At 10 years, the EFS rate for all patients is 63.4 +/- 3.3%, the survival rate 76.4 +/- 3.0%, the 5-year cumulative incidence of isolated CNS relapse 5.7 +/- 1.8%. The EFS rate at 10 years of the 127/218 (58.3%) patients with standard risk non-T-lineage ALL according to the NCI risk criteria was 67.9 +/- 4.3%, which is not significantly different from the results achieved in this category of patients with the moderately intensive treatment according to protocol ALL-6 (logrank P = 0.17). These DCLSG studies indicate that omission of cranial irradiation does not jeopardize the overall good results.

Antineoplastic Combined Chemotherapy Protocols↗

PubMed1996

A standard protocol for the evaluation of laser treatment of the prostate. The British Laser Urological Evaluation Society (BLUES)

OBJECTIVES: To present a standardized protocol, suitable for general use, for the evaluation of laser treatment of the prostate. METHODS: Many new operative treatments which are available to treat symptomatic prostatic enlargement are being accepted and offered to patients after scanty clinical evaluation, e.g. interventions using lasers. A consistent and standard protocol was developed, comprising data-recording sheets for patients' admission details, pre-operative assessments, operative details of laser ablation, post-operative in-patient progress and re-attendance, and subsequent out-patient follow-up. RESULTS: The protocol was tested by the members of BLUES and fulfilled their requirement for easy use in any department of Urology. It provides a simple way of accurately recording relevant data within a structured format with the additional advantage of permitting results to be expressed uniformly. CONCLUSION: The adoption of this protocol will allow valid comparisons of core data between studies assessing different procedures. The flexibility of the protocol enables it to be used, with minor modification, for the evaluation of any operative intervention aimed at relieving prostatic symptoms.

Clinical Protocols↗

PubMed1997

Oral narcotic protocol to reduce narcotic injections in refractory migraine patients.

Refractory headache patients who require narcotic injections for acute attacks frequently utilize health care facilities. The experience is often unpleasant and costly to the patient and health care system. We have developed an oral narcotic protocol for home administration. The patient starts with an antiemetic suppository, followed in 30 minutes by oral metoclopramide. After controlling nausea and vomiting, the patient administers a high dose of oral narcotic plus a hypnotic. The dosing of the narcotic analgesics incorporates seldom-used, but well-published pharmacokinetics. This protocol allows the patient to successfully treat a severe headache without using a health care facility. Eleven patients in our practice were prescribed the oral narcotic protocol. Their need for narcotic injections at our office or emergency department was monitored for up to 1 year before and after the start of the protocol. Combined office visits were reduced from 81 to 53 (34.6%) and emergency department visits from 47 to 26 (44.7%). An annual cost savings of $1960 for office visits and $3024 for emergency department visits was realized. This was offset by an oral narcotic protocol medication cost of only $392. This treatment method has been well accepted by patients and has proven to be a safe and cost-effective approach to treating refractory migraine patients.

Administration, Oral↗

PubMed2001

Protocol to prevent shoulder-hand syndrome after stroke.

OBJECTIVE: To determine the effectiveness of a protocol designed to restrict passive movement of affected upper extremity on the incidence of shoulder-hand syndrome (SHS) after stroke. DESIGN: Before-and-after trial: follow-up duration of subject group and historical control group 231.6 and 257.2 days, respectively. SETTING: Rehabilitation medicine department in a hospital in Japan. PARTICIPANTS SUBJECTS: 81 stroke patients treated with the protocol from 1994 to 1996 who were followed for at least 4 months from the onset of stroke; controls: 71 stroke patients treated without the protocol from 1991 to 1994 who were followed for same length of time. INTERVENTION: Use of a set protocol for controlled passive movement by trained therapists and restriction of passive movement by the patients for 4 months after stroke. The SHS criterion used to detect early signs of SHS has not yet been validated. Corticosteroids were given to all subjects diagnosed with SHS. MAIN OUTCOME MEASURES: Swelling index, SHS diagnostic criteria applied in physical exam, Brunnstrom stage, and sensory disturbance evaluations. RESULT: The incidence of SHS in the subject group was 18.5% (n = 15), whereas the incidence of SHS in the control group was 32.4% (n = 23). The difference between the 2 groups was statistically significant (chi(2) = 3.885, p < .05). CONCLUSION: The protocol helped to prevent development of SHS.

Chi-Square Distribution↗

PubMed1999

Hemoglobinopathy screening in pregnancy: comparison of two protocols.

This study was designed to determine the ability of a hemoglobinopathy screening protocol involving sickle solubility testing and red blood cell (RBC) indices to identify at-risk pregnancies. Retrospective chart review of all patients registering for prenatal care at the New York Hospital/Cornell Medical Center prenatal clinic in 1996 was the study design. All patients had RBC indices as well as hemoglobin electrophoresis. RBC indices of those with normal and abnormal electrophoreses were compared. Comparison of protocols involving universal hemoglobin electrophoresis and selective use of hemoglobin electrophoresis were compared. Student's t-test was used for statistical analysis. There were 36 carriers of hemoglobinopathy traits in 631 patients screened (5.7%). Four (three with hemoglobin C trait and one with hemoglobin D trait) had normal RBC indices and presumably would have had negative sickle solubility testing. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of a protocol with selective use of hemoglobin electrophoresis would have been 88.9, 79.4, 20.8, and 99.2%, respectively. Cost analysis reveals a difference of $11,384 or $18/patient less in a protocol with selective use of hemoglobin electrophoresis. Although a protocol involving solubility testing with RBC indices will not identify every carrier of a hemoglobinopathy trait, it may be appropriate in some populations.

Clinical Protocols↗

PubMedDate not supplied

The wreathing protocol: the imbrication of hypnosis and EMDR in the treatment of dissociative identity disorder and other dissociative responses. Eye Movement Desensitization Reprocessing.

Dissociative Identity Disorder (DID), a chronic childhood onset posttraumatic stress disorder, is currently recognized as a treatable condition. It is considered the paradigmatic dissociative condition and carries with it extreme posttraumatic symptomatology. Therapists skilled in the treatment of DID are typically fluent in the uses of hypnosis for stabilization, affect management, building a safe place and grounding to name of few. EMDR, which has come to the forefront of clinical awareness in the last ten years, seems aptly suited for the treatment of trauma, but can be destabilizing. This paper proposes a protocol, called Wreathing Protocol, for the imbricated use of EMDR and hypnosis in the treatment of not only DID (though this will be the primary focus of the paper), but also Dissociative Disorder Not Otherwise Specified (DDNOS) and chronic Posttraumatic Stress Disorder (PTSD). This protocol is useful to advanced clinicians skilled in both modalities independently. The sequential steps of the Wreathing Protocol will be described and illustrated by a clinical vignette on DID. The clinical implications of the use of the Wreathing Protocol will be discussed in DID as well as the chronic post traumatic spectrum.

Adult↗

PubMed2002

Protocols for the dosimetry of high-energy photon and electron beams: a comparison of the IAEA TRS-398 and previous international codes of practice. International Atomic Energy Agency.

A new international Code of Practice for radiotherapy dosimetry co-sponsored by several international organizations has been published by the IAEA, TRS-398. It is based on standards of absorbed dose to water, whereas previous protocols (TRS-381 and TRS-277) were based on air kerma standards. To estimate the changes in beam calibration caused by the introduction of TRS-398, a detailed experimental comparison of the dose determination in reference conditions in high-energy photon and electron beams has been made using the different IAEA protocols. A summary of the formulation and reference conditions in the various Codes of Practice, as well as of their basic data, is presented first. Accurate measurements have been made in 25 photon and electron beams from 10 clinical accelerators using 12 different cylindrical and plane-parallel chambers, and dose ratios under different conditions of TRS-398 to the other protocols determined. A strict step-by-step checklist was followed by the two participating clinical institutions to ascertain that the resulting calculations agreed within tenths of a per cent. The maximum differences found between TRS-398 and the previous Codes of Practice TRS-277 (2nd edn) and TRS-381 are of the order of 1.5-2.0%. TRS-398 yields absorbed doses larger than the previous protocols, around 1.0% for photons (TRS-277) and for electrons (TRS-381 and TRS-277) when plane-parallel chambers are cross-calibrated. For the Markus chamber, results show a very large variation, although a fortuitous cancellation of the old stopping powers with the ND,w/NK ratios makes the overall discrepancy between TRS-398 and TRS-277 in this case smaller than for well-guarded plane-parallel chambers. Chambers of the Roos-type with a 60Co ND,w calibration yield the maximum discrepancy in absorbed dose, which varies between 1.0% and 1.5% for TRS-381 and between 1.5% and 2.0% for TRS-277. Photon beam calibrations using directly measured or calculated TPR20,10 from a percentage dose data at SSD = 100 cm were found to be indistinguishable. Considering that approximately 0.8% of the differences between TRS-398 and the NK-based protocols are caused by the change to the new type of standards, the remaining difference in absolute dose is due either to a close similarity in basic data or to a fortuitous cancellation of the discrepancies in data and type of chamber calibration. It is emphasized that the NK-ND,air and ND,w formalisms have very similar uncertainty when the same criteria are used for both procedures. Arguments are provided in support of the recommendation for a change in reference dosimetry based on standards of absorbed dose to water.

Air↗

PubMed2004

Reduction in mortality from severe head injury following introduction of a protocol for intensive care management.

BACKGROUND: To determine the effect of an intensive care management protocol on the intensive care unit (ICU) and hospital mortality of severely head-injured patients, we designed a longitudinal observational study of all patients admitted with a head injury between 1992 and 2000. METHODS: A computerized patient database was used to identify all patients with severe head injury admitted to the ICU at Frenchay Hospital, Bristol, UK: a tertiary referral centre for the clinical neurosciences. We compared the ICU and hospital mortality and length of stay in patients before and after implementation of a protocol for their ICU management in 1997. RESULTS: Implementation of the protocol was associated with a significant reduction in ICU mortality from 19.95% to 13.5% (odds ratio 0.47; 95% CI 0.29-0.75), and in hospital mortality from 24.55% to 20.8% (odds ratio 0.48; 95% CI 0.31-0.74). This was achieved despite a significant increase in the median APACHE II score (14 vs 18) of patients admitted after implementation of the protocol. The median ICU and hospital length of stay remained constant over the study period. CONCLUSIONS: The introduction of an evidence-based protocol to guide the ICU management of patients with severe head injury has been associated with a significant reduction in both ICU and hospital mortality.

APACHE↗

PubMed1993

An investigation of awareness of antenatal protocols.

Previous audit at the Homerton Hospital had revealed a poor level of compliance with established antenatal protocols mandated by risk factors detected at the booking visit. Medical staff were questioned as to their awareness of five of the most important protocols and their response was analysed by a new scoring system. The scores were generally low though consultants scored more highly than junior staff. Scores were related to the length of obstetric experience and duration of work in the obstetric unit but were not related to frequency of the use of the protocol manual nor to the last time that reference was made to the manual. To improve compliance within the unit, the following recommendations were made: (1) regular revision of protocols to incorporate the current views of senior clinicians and (2) improved dissemination of information. The scoring system described here should prove to be a simple and effective method for the assessment of protocols within any unit.

Awareness↗

PubMedDate not supplied

Development of an alcohol withdrawal protocol: CNS collaborative exemplar.

PURPOSE: The purpose of this process improvement project was to develop an Alcohol Withdrawal Syndrome (AWS) management protocol for acute care. SIGNIFICANCE: The prevalence of alcohol abuse in our society presents challenges for health professionals, and few nurses have received formal education on the identification and treatment of AWS, which has frequently resulted in ineffective, nonstandardized care. However, nurses practicing in medical-surgical, emergency, trauma, and critical care settings must be astute in the assessment and management of AWS. DESIGN/BACKGROUND/RATIONALE: Following an analysis of existing management protocols, a behavioral health clinical nurse specialist was asked to lead a work team composed of physicians, pharmacists, and nurses to develop a new evidence-based alcohol withdrawal protocol for acute care. METHODS/DESCRIPTION: By implementing a standardized assessment tool and treatment protocol, clinical nurse specialists empowered nursing staff with strategies to prevent the serious medical complications associated with AWS. FINDINGS/OUTCOMES: The development and integration of a safe and effective treatment protocol to manage AWS was facilitated by collaborative, evidence-based decision making. CONCLUSION: Clinical experience and specialty expertise were integrated by clinical nurse specialists skilled in group dynamics, problem-solving, and the implementation of change. Improving care of patients in AWS is an exemplar for clinical nurse specialist roles as change agent and patient advocate.

Acute Disease↗

PubMed1999

An ultrashort 1-day protocol of Tc-99m tetrofosmin.

PURPOSE: This study describes a new 1-day protocol with Tc-99m tetrofosmin that requires only 100 minutes to obtain both stress and resting cardiac images by using a double-injection and subtraction method. METHODS: This procedure was performed in 48 consecutive patients. Rest-rest double injections were performed in eight patients (five men, three women; mean age, 69 +/- 9.8 years ) to evaluate count and image reproducibility (subprotocol A), and stress-rest and additional resting perfusion images (true rest) were done on a different day in 11 patients (five men, six women; mean age, 63 +/- 5.9 years) to confirm the validity of the new protocol (subprotocol B). RESULTS: Image quality scores of the resting image were excellent (35 of 48, or 72.9%), good (7 of 48, or 14.6%), fair (3 of 48, or 6.3%), and poor (3 of 48, or 6.3%). The scintigraphic findings with the new protocol corresponded closely with those of angiography in 26 of 34 cases (76.5%), with a tendency for underestimation (in 5 of 34 cases, or 14.7%) rather than overestimation (in 3 of 34 cases, or 8.8%). In subprotocol A, count reproducibility between the two resting images was excellent (r = 0.95; P < 0.0001); and in subprotocol B, the early-rest images were concordant visually and quantitatively with the true rest images (r = 0.89, P < 0.0001). CONCLUSION: Although there are some limitations, this protocol can be used as a routine stress-rest protocol.

Aged↗

PubMed2000

Identification of neonatal hearing impairment: experimental protocol and database management.

OBJECTIVE: The purposes of this article are to describe the overall protocol for the Identification of Neonatal Hearing Impairment (INHI) project and to describe the management of the data collected as part of this project. A well-defined protocol and database management techniques were needed to ensure that data were 1) collected accurately and in the same way across sites; 2) maintained in a database that could be used to provide feedback to individual sites regarding enrollment and the extent to which the protocol was complete on individual subjects; and 3) available to answer project questions. This article describes techniques that were used to meet these needs. DESIGN: This study was a prospective, randomized study that was designed to evaluate auditory brain stem responses, transient evoked otoacoustic emissions, and distortion product otoacoustic emissions as hearing-screening tools, and to relate neonatal test findings to hearing status, defined by visual reinforcement audiometry at 8 to 12 mo of age. Measures of middle-ear function also were obtained at some sites as part of the neonatal test battery. In addition, other clinical and demographic data were gathered to determine the extent to which factors, other than auditory status, influenced test behavior. Three groups were evaluated: neonatal intensive care unit (NICU) infants (those who spent 3 or more days in a NICU), well babies with risk factors for hearing loss, and well babies without risk factors. Six centers participated in the trial. The testers for the project included audiologists, technicians, audiology graduate students, and medical research staff. The same computerized neonatal test program was applied at each center. This program generated the neonatal test database automatically. Clinical and demographic data were collected by means of concise data collection forms and were entered into a database at each site. After the neonatal test, subjects from the NICU and at-risk well babies were evaluated with visual reinforcement audiometry starting at 8 to 12 mo of age. All data were electronically transmitted to the core site where they were merged into one overall database. This database was exercised to provide feedback and to identify discrepancies throughout the course of the study. In its final form, it served as the database on which all analyses were performed. RESULTS AND CONCLUSION: The protocol was a departure from typical hearing screening procedures in terms of 1) its regimented application of three screening measures; 2) the detailed information that was obtained regarding subject clinical and demographic factors; and 3) its application of the same procedures across six centers having diverse geographic location and subject demographics. A learning curve for successfully executing the study protocols was observed. Throughout the study, monthly reports were generated to monitor subject enrollment, check for data completeness, and to perform data integrity checks. In combination with monthly data reports and checks that occurred throughout the progression of the study, miscellaneous data audits were performed to check accuracy of neonatal testing programs and to cross-check information entered in the clinical and demographic database. The data management techniques used in this project helped to ensure the quality of the data collection process and also allowed for detailed analyses once data were collected. This was particularly important because it enabled us to evaluate not only the performance of individual measures as screening tools, but also permitted an evaluation of the influence of other variables on screening test results.

Acoustic Stimulation↗

PubMed2001

A new cervical spine clearance protocol using computed tomography.

OBJECTIVE: The purpose of this study was to assess a cervical spine clearance protocol for blunt trauma patients using helical computed tomographic (CT) scan of the cervical spine (C-spine). METHODS: A protocol using CT scan of the C-spine was implemented and the first 6 months of use reviewed. Patients requiring a CT scan of the head had the C-spine evaluated by lateral C-spine radiography and a helical CT scan. Patients without indication for CT scan of the head had the C-spine evaluated by three-view radiography (anteroposterior, lateral, and odontoid) with selective CT scan of the C-spine for imaging areas not well visualized or those with abnormalities identified by radiography or by clinical examination alone. RESULTS: Three hundred twenty-four patients were admitted to the trauma center after blunt trauma during the first 6 months of protocol implementation. Head CT scans were obtained in 158 patients and lateral cervical spine radiography in conjunction with helical CT scanning evaluated the C-spine. The other 166 patients had the cervical spine cleared by three-view radiography series or by clinical examination alone. For patients in whom a head CT scan was not indicated, CT scanning was used only when plain radiographs failed to adequately visualize the entire C-spine. A total of 15 injuries (4.6% of the group) were detected. Seven injuries were suspected or detected by lateral plain radiographs and confirmed by CT scan. Six patients had an injury not detected by radiography but diagnosed by CT scan, and one patient had a false-positive radiograph. Of the remaining two injuries, one was diagnosed by magnetic resonance imaging and the other by CT scan outside of the protocol. Lateral plain radiographs alone failed to detect 46% (n = 6) of all injuries. CONCLUSION: In our series, the selective use of helical CT scanning with plain radiography increased the accuracy with which cervical spine injury was detected from 54% to 100%. The protocol allowed for more rapid evaluation in many patients as well. We recommend that practice guidelines include the use of helical CT scan of the entire C-spine as the diagnostic procedure for those blunt trauma patients undergoing CT scanning of the head.

Adult↗

PubMed1995

Hyperacuity test to evaluate vision through dense cataracts; research preliminary to a clinical study. II. Initial trials of the India instrument and HASP protocol at Aravind Eye Hospital, Madurai, India.

BACKGROUND. Our purpose is to develop a clinical test capable of assessing vision through dense cataracts (and other advanced media opacities) before surgery. Because such anomalies are endemic in the developing world, it was desirable to conduct a clinical study of a prototype India instrument and HyperAcuity Study Protocol (HASP) in such a setting. This investigation, preliminary to a planned clinical study, was conducted at the Aravind (Free) Eye Hospital, Madurai, India. EXPERIMENTAL. The preliminary HASP protocol, developed in Berkeley, was adapted to existing clinical practices in Madurai. Included was a new test of visual acuity, the Gap "VA" test, developed as part of the revised protocol. The rational for this test, methods used, and sample data are presented. A Vernier alignment test (one of the hyperacuities) is used to assess vision through dense ocular media disorders. The task of the patient is to align vertically three high luminance, discrete visual stimuli. The revised HASP protocol and adapted India instrument were tested upon patients with advanced cataracts. The cataract grading system used in these studies (provided by Drs. N. V. Projna and G. Rohini) is defined. Patients were tested before and shortly after surgery. This investigation allowed us to refine the test protocol and instrument design preparatory for a clinical study of HASP. A much simpler/cheaper version of the India instrument will be used in the planned clinical study. Additional experiments are scheduled in order to address issues which require resolution before initiation of next-stage testing. In part, in these papers, we seek to help others understand some problems encountered when conducting research in a developing world environment, even a very good one!

Aged↗