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PubMed1991

Manual resuscitators and spontaneous ventilation--an evaluation.

BACKGROUND AND METHODS: Although it is useful in certain clinical situations for manual resuscitator units to be used with spontaneously ventilating patients, there are few data regarding their performance in these settings. We measured the percent-delivered oxygen from 13 adult manual resuscitator units during simulated spontaneous ventilation in the range of respiratory frequency, tidal volume, and oxygen supply in which manual resuscitator units might be used with patients. We also measured the resistive pressure developed during simulated ventilation and at constant inspiratory flow of 50 L/min. RESULTS: Oxygen supply, tidal volume, minute ventilation, and reservoir volume all influenced percent-delivered oxygen, but the most important determinant of percent-delivered oxygen was valve design. Valves incorporating a "disc" element to prevent air entrainment from the expiratory port gave the most efficient oxygen delivery, while "duck-bill" valves did not reliably prevent air entrainment. Only two of the manual resuscitator units tested developed high resistive pressure. CONCLUSION: Reliable administration of high percent-delivered oxygen to spontaneously ventilating patients, while retaining the capability to manually ventilate them, is best achieved by a manual resuscitator unit with a valve of low resistance, incorporating a disc to prevent air entrainment. We recommend that manufacturers indicate on the product information sheet the degree (and confidence limits) to which their manual resuscitator unit presents resistance and delivers oxygen to a spontaneously ventilating subject.

Airway Resistance↗
PubMed2004

Gated blood-pool SPECT automated versus manual left ventricular function calculations.

Planar gated blood-pool imaging (GBPI) is a standard method for non-invasive assessment of left ventricular (LV) function. Gated blood-pool single photon emission computed tomographic (GBPS) data acquisition can be accomplished in the same time as GBPI, with the benefit of enabling visualization of all cardiac chambers simultaneously. The purpose of this investigation was to evaluate the degree to which automated and manual LVEF calculations agree with one another and with conventional GBPI LVEF measurements. GBPI studies were performed in 22 consecutive, unselected patients, followed by GBPS data acquisition. GBPS left ventricular ejection fraction (LVEF) calculations were performed by available software (NuSMUGA, Northwestern University, Chicago, IL) automatically and manually, using all LV gated short axis slices. Automatic LVEF assessed by GBPS correlated well with conventional planar GBPI (r = 0.88, P < 0.001). Mean planar GBPI LVEF was 50% +/- 12%, and mean GBPS automatic LVEF was significantly lower at 45% + 14% (P = 0.001), with a mean difference of 6% +/- 5%. Manual GBPS LVEF also correlated well with conventional planar GBPI (r = 0.90, P < 0.0001). Mean LVEF measurement by manual GBPS versus GBPI was significantly higher at 59% +/- 13%, with a mean difference of 10% +/- 6% (P < 0.001). Manual GBPS LVEF values were also significantly higher than automatically determined GBPS LVEF values (P < 0.001). It is concluded that LVEF values assessed by NuSMUGA GBPS software were reproducible, and automatic and manual values correlated well with conventional GBPI values. However, both automatic and manual GBPS calculations were significantly different from one another and from GBPI values, so that GBPI and NuSMUGA calculations cannot be considered to be equivalent.

Adult↗
PubMed2004

Manual versus electric vacuum aspiration for early first-trimester abortion: a controlled study of complication rates.

OBJECTIVE: Manual vacuum aspiration is an alternative to electric suction curettage for first-trimester elective abortion. Although many studies have demonstrated that manual vacuum aspiration is safer than sharp curettage for abortion, only a few studies have directly compared it with electric suction curettage. These studies proved the methods to be equally effective and acceptable but were too small to adequately compare safety. We compared immediate complication rates for abortions performed by manual and electric vacuum aspiration. METHODS: We conducted a retrospective cohort analysis of all women undergoing elective abortion at up to 10 weeks' gestation at San Francisco General Hospital over a 3.5-year period. A total of 1726 procedures were included: 1002 manual and 724 electric vacuum aspirations. Clinical data were collected from medical records. Rates of uterine reaspiration and other immediate complications occurring at our institution were compared. RESULTS: We found no difference in the rate of uterine reaspiration after abortions performed with the manual or electric suction device (2.2% versus 1.7%, respectively, P =.43). We had 80% statistical power to detect a 2% difference in uterine reaspiration rates with an microa error of.05. Overall major complication rates were 2.5% with manual and 2.1% with electric suction curettage, P =.56. Multivariable regression analyses controlling for potential confounders showed no difference in uterine reaspiration rates (electric odds ratio [OR] = 0.71, 95% confidence interval [CI] 0.32, 1.6) or overall complications (electric OR = 0.81, 95% CI 0.40, 1.7). CONCLUSION: Manual vacuum aspiration is as safe as electric suction curettage for abortions at up to 10 weeks' gestation. Expanded use in an office setting might increase abortion access.

Abortion, Induced↗
PubMed2005

A randomized trial of misoprostol compared with manual vacuum aspiration for incomplete abortion.

OBJECTIVE: To compare the safety, efficacy, and acceptability of misoprostol and manual vacuum aspiration for the treatment of incomplete abortion in a hospital setting in Kampala, Uganda. METHODS: Three hundred seventeen women with clinically diagnosed incomplete first-trimester abortions were randomized to treatment with either manual vacuum aspiration or 600 mug misoprostol orally to complete their abortions. All women received antibiotics posttreatment and were followed up 1-2 weeks later. RESULTS: Regardless of treatment allocation, nearly all women in this study successfully completed their abortions with either oral misoprostol or manual vacuum aspiration (96.3% versus 91.5%, relative risk 1.05, 95% confidence interval 0.98-1.14). Complications were less frequent in those receiving misoprostol than those having manual vacuum aspiration (0.9% versus 9.8%, relative risk 0.1, 95% confidence interval 0.01-0.78). In the 6 hours after treatment, women using misoprostol reported heavier bleeding but lower levels of pain than those treated with manual vacuum aspiration. Rates of acceptability were similarly high among women in the 2 treatment groups, with 94.2% and 94.7% of women reporting that their treatment was satisfactory or very satisfactory in the misoprostol and manual vacuum aspiration groups, respectively. CONCLUSION: For treatment of first-trimester uncomplicated incomplete abortion, both manual vacuum aspiration and 600 microg oral misoprostol are safe, effective, and acceptable treatments. Based on availability of each method and the wishes of individual women, either option may be presented to women for the treatment of incomplete abortion. LEVEL OF EVIDENCE: I.

Abortifacient Agents, Nonsteroidal↗
PubMed2007

Endothelial cell density in donor corneas: a comparison of automatic software programs with manual counting.

PURPOSE: Several automated systems have become available to determine endothelial cell density (ECD) of donor corneas. The purpose of this study was the comparison of 2 systems, the Endothelial Analysis System EAT V1.4 (Rhinetec, Duesseldorf, Germany) and the NAVIS Cell Count Version 3.4.1 (Nidek Technologies, Erlangen, Germany), against manual ECD counts. METHODS: During organ culture, the endothelium of 50 human corneas was photographed on both conventional film and digitally. Manual fixed-frame counting was performed on 2 photographs by 3 experienced ophthalmologists. Three digital pictures of each cornea were analyzed semiautomatically on the Rhinetec EAT system V1.4. Images were imported and analyzed by the fully automatic mode of the NAVIS system V3.4.1 (which also offers a semiautomatic counting mode). In an additional experiment on 11 corneas, the NAVIS counts on the microscopy system previously used only for manual cell counts were directly compared with manual counts. RESULTS: Mean endothelial cell density obtained by manual counting of all observers was 2679 +/- 313 (SD) cells/mm. Values obtained by digital analysis with EAT were a mean of 1.3% higher (2713 +/- 286 cells/mm), which is not a significant difference. In contrast, analysis of the digital pictures with the fully automated NAVIS software mode showed a mean of 7.0% higher measurements (2867 +/- 111 cells/ mm), a significant difference (P = 0.0001). Altman-Bland analysis revealed that the fully automated NAVIS counts gave too low results for high ECDs and too high results for low ECDs. This result was confirmed by the direct comparison with manual counting. CONCLUSIONS: Fully automated analysis of ECD remains problematic. Validation of any computer-assisted system against manual counting is of importance.

Adolescent↗
PubMed1986

Gingival abrasion and plaque removal with manual versus electric toothbrushing.

A clinical trial was designed to test the relative numbers of gingival lesions caused during standardized brushing of the teeth of 22 volunteer dental nurse students with a manual soft multitufted, a manual soft V-shaped, and an electric toothbrush. First, the left or the right side of the jaws of each subject was brushed by a dental hygienist using the manual V-shaped or the electric brush, and the other side using the manual multitufted brush. At the 2nd brushing 1 week later, the same hygienist used the multitufted brush for brushing the side contralateral to the one in which it was used the 1st week and the V-shaped manual brush instead of the electric and vice versa. After each brushing, the number of new gingival lesions was recorded and the cleansing effect evaluated by assessment of the amount of remaining plaque. This examiner was unaware of the type of brush used. The V-shaped manual toothbrush was found to have caused more gingival abrasion than the electric toothbrush (P less than 0.005) and a similar difference was found between the multitufted manual and the electric toothbrush (P less than 0.05). There was no clinically significant difference between the plaque removing effects of the 3 brushes tested.

Dental Plaque↗
PubMed2004

A clinical comparison of an oscillating/rotating powered toothbrush and a manual toothbrush in patients with chronic periodontitis.

OBJECTIVES PRIMARY OBJECTIVE: To compare the relative efficacy of an oscillating/rotating powered toothbrush to that of a conventional manual toothbrush in a group of periodontal patients over a 16-month period with respect to plaque control. SECONDARY OBJECTIVE: To compare differences in pocket depth (PD) and bleeding index (BI) between the two groups over a 16-month period. MATERIAL AND METHODS: Forty patients were recruited to a 16-month, single-blind, two-group, randomised, parallel group clinical trial to compare the effects of manual and oscillating/rotating powered toothbrushes in a cohort of patients with chronic periodontitis. None of the patients had previous experience of using an oscillating/rotating brush and had a mean plaque index (PI) of > 2.0 (modified Quigley and Hein index) at baseline. Patients were stratified by gender, age and smoking status then randomised to using a manual or an oscillating/rotating brush for the duration of the study. Conventional non-surgical periodontal therapy was undertaken within the first month after baseline. PI was the primary outcome measure with PDs and BI also recorded at baseline and months 3, 6, 10 and 16. RESULTS: Mean full-mouth (FM) scores at baseline for oscillating/rotating brushing and manual brushing groups were as follows: PI, 3.4 and 3.5; BI, 1.7 and 1.5; and PD, 3.4 and 3.3. The mean reduction in FM scores from baseline to 16 months were: PI, 0.72 and 0.75; PD, 0.43 and 0.57; and BI, 0.74 and 0.83, respectively. Repeated measures ANOVA were used to compare differences between groups (adjusted for baseline levels) at months 3, 6, 10 and 16 and showed no statistically significant difference between groups for PI and PD (p > 0.05). A difference of 0.2 BI units was detected in favour of the manual brushing group (p = 0.04). CONCLUSION: Over a 16-month period, there were no differences in PI reduction or PD reduction between patients who underwent non-surgical management of chronic periodontal disease and used either an oscillating/rotating powered toothbrush or a conventional manual toothbrush. A difference in gingival bleeding reduction was detected in favour of the patients allocated the manual brush.

Adult↗
PubMed1992

Radiographic osteoarthrosis in the acromioclavicular joint resulting from manual work or exposure to vibration.

The hypothesis that manual work and exposure to vibration are antecedents to the development of osteoarthrosis was assessed employing a cross sectional study design. The frequency of osteoarthrosis in the acromioclavicular joint was studied in three groups of workers in the construction industry. Two groups were manual workers (54 bricklayers and 55 rock blasters); the third group consisted of 98 foremen. The radiographic appearance of the right and left acromioclavicular joints was classified into one of five grades of osteoarthrosis. A protocol was developed to assess exposure on the basis of job title, years of manual work, total weight lifted during working life, and total hours of exposure to vibrating tools. Odds ratios for job titles (manual worker v foreman) and for years of manual work as indicators of exposure were of similar magnitude of around 2.5. Construction workers who had lifted more than 709 tonnes had an increased risk of developing severe osteoarthrosis of the right acromioclavicular joint, odds ratio: 2.62 (95% confidence interval (95% CI), 1.13-6.06). The odds ratio for the left side was 7.67 (95% CI, 2.76-21.34). In the analysis of vibration exposure, workers who had been highly exposed to vibration had an odds ratio of 1.99 (95% CI, 1.00-3.92) on the right side and 2.20 (95% CI, 1.07-4.56) on the left. This effect almost disappeared after simultaneous adjustment for manual work. Occupational and ergonomic factors, such as the sum of lifted tonnes during working life, job title, and the sum of years of manual work seem to be risk factors for osteoarthrosis of the acromioclavicular joint, whereas vibration alone was a weaker risk factor.

Acromioclavicular Joint↗
PubMed2004

Liver segmentation in living liver transplant donors: comparison of semiautomatic and manual methods.

PURPOSE: To compare the accuracy and repeatability of a semiautomatic segmentation algorithm with those of manual segmentation for determining liver volume in living liver transplant donors at magnetic resonance (MR) imaging. MATERIALS AND METHODS: The institutional review board approved this retrospective study and waived the requirement for informed consent. The semiautomatic segmentation algorithm is based on geometric deformable models and the level-set technique. It entails (a) placing initialization circle(s) on each image section, (b) running the algorithm, (c) inspecting and possibly manually modifying the contours obtained with the segmentation algorithm, and (d) placing lines to separate the liver segments. For 18 living donors (eight men and 10 women; mean age, 34 years; age range, 25-46 years), two observers each performed two semiautomatic and two manual segmentations on contrast material-enhanced T1-weighted MR images. Each measurement was timed. Actual graft weight was measured during surgery. The time needed for manual and that needed for semiautomatic segmentation were compared. Accuracy and repeatability were evaluated with the Bland-Altman method. RESULTS: Mean interaction time was reduced from 25 minutes with manual segmentation to 5 minutes with semiautomatic segmentation. The mean total time for the semiautomatic process was 7 minutes 20 seconds. Differences between the actual volume and the estimated volume ranged from -223 to +123 mL for manual segmentation and from -214 to +86 mL for semiautomatic segmentation. The 95% limits of agreement for the ratio of actual graft volume to estimated graft volume were 0.686 and 1.601 for semiautomatic segmentation and 0.651 and 1.957 for manual segmentation. Semiautomatic segmentation improved estimation in 15 of 18 cases. Inter- and intraobserver repeatability was higher with semiautomatic segmentation. CONCLUSION: Use of the semiautomatic segmentation algorithm substantially reduces the time needed for volumetric measurement of liver segments while improving both accuracy and repeatability.

Adult↗
PubMed2006

CT colonography: automated measurement of colonic polyps compared with manual techniques--human in vitro study.

PURPOSE: To prospectively investigate the relative accuracy and reproducibility of manual and automated computer software measurements by using polyps of known size in a human colectomy specimen. MATERIALS AND METHODS: Institutional review board approval was obtained for the study; written consent for use of the surgical specimen was obtained. A colectomy specimen containing 27 polyps from a 16-year-old male patient with familial adenomatous polyposis was insufflated, submerged in a container with solution, and scanned at four-section multi-detector row computed tomography (CT). A histopathologist measured the maximum dimension of all polyps in the opened specimen. Digital photographs and line drawings were produced to aid CT-histologic measurement correlation. A novice (radiographic technician) and an experienced (radiologist) observer independently estimated polyp diameter with three methods: manual two-dimensional (2D) and manual three-dimensional (3D) measurement with software calipers and automated measurement with software (automatic). Data were analyzed with paired t tests and Bland-Altman limits of agreement. RESULTS: Seven polyps (<or=6-mm diameter) could not be extracted by using the software; 20 polyps (5-15-mm diameter) remained for analysis. Automated measurement was not significantly different from histologic size for the experienced reader (mean difference, 0.63 mm; P=.06) or novice reader (mean difference, 0.58 mm; P=.12). With manual 2D measurement and manual 3D measurement, the experienced reader (1.21-mm mean difference, P<.001, and 0.68-mm mean difference, P=.03, respectively) and novice reader (1.54-mm mean difference, P<.001, and 0.84-mm mean difference, P=.002, respectively) significantly underestimated polyp size. Interobserver agreement was good and similar for all three methods (95% limits of agreement span, approximately 2.5 mm). Intraobserver agreement was related to reader experience, with differences of up to 2.5 mm within expected limits of agreement. CONCLUSION: For polyps smaller than 1 cm, measurement differences of up to 2.5 mm are within the expected limits of inter- and intraobserver agreement for all measurement techniques. Automated and manual 3D polyp measurements are more accurate than manual 2D measurements.

Adolescent↗
PubMed1999

Brain tumor volume measurement: comparison of manual and semiautomated methods.

PURPOSE: To compare the reliability of two approaches to measuring enhancing brain tumor volumes--the conventional manual trace method and a threshold-based, semiautomated computer software method. MATERIALS AND METHODS: Two operators rated contrast material-enhanced, T1-weighted axial magnetic resonance (MR) image data sets from 16 patients aged 21-71 years with high-grade gliomas. Each MR data set was rated twice by using manual tracing and twice by using the semiautomated method. The semiautomated measurement method involved a thresholding algorithm based on mixture modeling. The data collection time for each method was recorded. Reliability was measured by using inter- and intraoperator agreement indexes. RESULTS: Mean intraoperator agreement indexes (+/- SD) were 0.90 +/- 0.09 (operator 1) and 0.83 +/- 0.15 (operator 2) for the manual trace method and 0.83 +/- 0.17 (operator 1) and 0.84 +/- 0.16 (operator 2) for the semiautomated measurement method. The mean interoperator agreement was 0.85 +/- 0.14 for the manual method and 0.82 +/- 0.18 for the semiautomated method. The semiautomated method was faster than the manual trace method by an average of 4.6 minutes per patient. CONCLUSION: The semiautomated computer method of measuring tumor volume was faster than the manual trace method. Semiautomated computer approaches offer an alternative to manual tracing for measuring serial tumor volumes in patients with high-grade brain neoplasms.

Adult↗
PubMed2000

An investigation of the early effects of manual lung hyperinflation in critically ill patients.

This prospective within-group multicentre study was designed to assess the safety and short-term effectiveness of manual lung hyperinflation in mechanically ventilated patients. Eighteen patients from the intensive care units of two tertiary institutions were included and acted as their own control. Manual lung hyperinflation treatment involved patient positioning (side-lying), suctioning and manual lung hyperinflation. Side-lying treatment involved patient positioning and suctioning alone. Patients received both treatments on the day of data collection. Results demonstrated significant improvement for static respiratory system compliance (P = 0.001) with manual lung hyperinflation treatment compared to side-lying treatment. Manual lung hyperinflation treatment also cleared a significantly greater wet weight of sputum (P = 0.039). There were no differences between manual lung hyperinflation and side-lying treatment for gas exchange (PaO2/FIO2 and PaCO2), mean arterial pressure or heart rate. In conclusion, total static respiratory system compliance and sputum clearance were improved by the addition of manual hyperinflation to a physiotherapy treatment of positioning and suctioning in mechanically ventilated patients without compromise to cardiovascular stability or gas exchange.

Adult↗
PubMedDate not supplied

Quantification of anterior translation of the humeral head in the throwing shoulder. Manual assessment versus stress radiography.

Clinical evaluation of humeral head translation relies mainly on manual tests to measure laxity in the human shoulder. The purposes of this study were to determine whether side-to-side differences exist in anterior humeral head translation in professional baseball pitchers, to compare manual laxity testing with stress radiography for quantifying humeral head translation, and to test intrarater reliability of the manual humeral head translation and stress radiography tests. Twenty professional baseball pitchers underwent bilateral manual anterior humeral head translation and stress radiographic tests. Stress radiography was performed by imparting a 15-daN anterior load to the shoulder in 90 degrees of abduction with both neutral and 60 degrees of external rotation and recording the glenohumeral joint translation at rest and under stress in each position. Eight subjects were retested to assess the reliability of these methods. Results showed no significant difference between the dominant and nondominant extremity in the amount of anterior humeral head translation measured manually and with stress radiography, nor significant correlation between anterior humeral head translation measured manually and by stress radiography. Test-retest reliability was moderate-to-poor for the manual humeral head translation test and moderate for stress radiography.

Adolescent↗
PubMed2006

Radiographic angles in hallux valgus: differences between measurements made manually and with a computerized program.

BACKGROUND: The objective of this study was to compare angular measurements in the evaluation of hallux valgus deformities using a goniometer and a computerized program to assess degree of concordance between the two methods and determine the reliability of manual measurements. METHODS: Angles measured included the hallux valgus angle (HVA), the intermetatarsal angle (IMA), the distal metatarsal articular angle (DMAA), and the proximal phalangeal articular angle (PPAA), also called the hallux valgus interphalangeus angle or interphalangeal angle. Measurements were made on preoperative weightbearing radiographs in 176 patients with symptomatic hallux valgus. Manual measurements were made with a goniometer by an orthopaedic surgeon. An independent experienced technician used digitized images to perform angular measurements with the Autocad software program (Autodesk Inc., San Rafael, CA). RESULTS: HVA values obtained with the two techniques were similar. However, significantly higher mean values were obtained with the Autocad for the IMA and PPAA measurements, and higher mean values were obtained for the DMAA measurement with the manual technique. Whereas differences were more or less randomly distributed for the HVA, in the remaining patients, measurements were clearly related to the measurement technique, i.e., for the DMAA, the manual technique had a tendency to show higher values, and for the IMA and PPAA the manual technique showed lower values than the computer. Correlations between both techniques for the different angular measurements were as follows: HVA, -0.179 (p = 0.018); DMMA, -0.294 (p < 0.001); PPAA, -0.876 (p < 0.001); and IMA, -0.661 (p < 0.001). The intraclass correlation coefficient (ICC) showed that the concordance between manual and Autocad angular measurements was excellent for the HVA (ICC = 0.89) and DMAA (ICC = 0.80) and very poor for the PPAA (ICC = 0.11) and IMA (ICC = 0.42). CONCLUSIONS: Angular measurements made on weightbearing radiographs with the Autocad in patients with hallux valgus deformities were more reliable than those made with a goniometer. Although for large angles, such as HVA and DMAA, results obtained with both measurement techniques were similar. Manual measurements, however, may underestimate the true values of the smaller IMA and PPAA angles.

Hallux Valgus↗
PubMed2001

Manual differential cell counts help predict bacterial infection. A multivariate analysis.

We developed logistic regression models that combine information from the automated CBC and manual 100-cell differential counts to predict bacterial infection. The logistic models were fitted from a case group of 116 patients with proven bacterial infection and a control group of 930 presumably uninfected outpatients. A 4-variable, 15-parameter model, which includes automated absolute neutrophil, manual band, and manual immature granulocyte counts, performed best with a receiver operating characteristic (ROC) curve area of 89%. A more practical 2-variable model including automated absolute neutrophil and manual band counts performed almost as well with an ROC curve area of 86%. The automated neutrophil count-only model is less informative with an ROC curve area of 78%. The combined information from automated and manual differential cell counts more accurately predicts bacterial infection than automated counting alone. Despite these modest improvements, the high cost of manual differential cell counts dictates careful patient selection. The supplemental information gained from manual differential counts is most useful for patients with low to normal neutrophil counts (8,000/microL [8.0 x 10(9)/L] or less). Further studies are indicated to determine the characteristic patient populations deriving maximal benefit from this information.

Adolescent↗
PubMed2000

Successful manual reduction of locked metacarpophalangeal joints in fingers.

BACKGROUND: Many studies on the etiology and operative treatment of locked metacarpophalangeal joints in fingers have been reported, but there have been few investigations on manual reduction. The rate of success of manual reduction in previous reports has been low, and no consensus has been reached with regard to the best method of manual reduction. On the basis of our experience with operative treatment, we devised a safe method of manual reduction. METHODS: Between January 1987 and December 1995, we reduced a locked metacarpophalangeal joint in twelve female patients; every locked finger was successfully reduced, and complications such as fracture did not occur during manual reduction. The average duration of follow-up was five years and nine months (range, three years and two months to nine years and three months). RESULTS: Six patients had no recurrence of the locking. Four of the six remaining patients had one or two incidents of locking, had no alteration in the activities of daily living, and did not want operative treatment. The two remaining patients reported that they had incidents of locking several times a day, and they requested operative treatment as they were afraid of additional recurrences. One patient had an open reduction fifteen months after the initial episode of locking, and the other patient elected not to have an operation for personal reasons. CONCLUSIONS: We believe that our method of manual reduction should be used to treat a locked metacarpophalangeal joint in a finger and that operative treatment should be limited to patients in whom manual reduction is unsuccessful or the reduction is unstable.

Adult↗
PubMed2002

Standardisation of costs: the Dutch Manual for Costing in economic evaluations.

The lack of a uniform costing methodology is often considered a weakness of economic evaluations that hinders the interpretation and comparison of studies. Standardisation is therefore an important topic within the methodology of economic evaluations and in national guidelines that formulate the formal requirements for studies to be considered when deciding on the reimbursement of new medical therapies. Recently, the Dutch Manual for Costing: Methods and Standard Costs for Economic Evaluations in Health Care (further referred to as "the manual") has been published, in addition to the Dutch guidelines for pharmacoeconomic research. The objectives of this article are to describe the main content of the manual and to discuss some key issues of the manual in relation to the standardisation of costs. The manual introduces a six-step procedure for costing. These steps concern: the scope of the study;the choice of cost categories;the identification of units;the measurement of resource use;the monetary valuation of units; andthe calculation of unit costs. Each step consists of a number of choices and these together define the approach taken. In addition to a description of the costing process, five key issues regarding the standardisation of costs are distinguished. These are the use of basic principles, methods for measurement and valuation, standard costs (average prices of healthcare services), standard values (values that can be used within unit cost calculations), and the reporting of outcomes. The use of the basic principles, standard values and minimal requirements for reporting outcomes, as defined in the manual, are obligatory in studies that support submissions to acquire reimbursement for new pharmaceuticals. Whether to use standard costs, and the choice of a particular method to measure or value costs, is left mainly to the investigator, depending on the specific study setting. In conclusion, several instruments are available to increase standardisation in costing methodology among studies. These instruments have to be used in such a way that a balance is found between standardisation and the specific setting in which a study is performed. The way in which the Dutch manual tries to reach this balance can serve as an illustration for other countries.

Health Care Costs↗
PubMed2000

Comparison of supervised exercise with and without manual physical therapy for patients with shoulder impingement syndrome.

STUDY DESIGN: A prospective randomized clinical trial. OBJECTIVE: To compare the effectiveness of 2 physical therapy treatment approaches for impingement syndrome of the shoulder. BACKGROUND: Manual physical therapy combined with exercise is a commonly applied but currently unproven clinical treatment for impingement syndrome of the shoulder. METHODS AND MEASURES: Thirty men and 22 women (age 43 years +/- 9.1) diagnosed with shoulder impingement syndrome were randomly assigned to 1 of 2 treatment groups. The exercise group performed supervised flexibility and strengthening exercises. The manual therapy group performed the same program and received manual physical therapy treatment. Both groups received the selected intervention 6 times over a 3-week period. The testers, who were blinded to group assignment, measured strength, pain, and function before treatment and after 6 physical therapy visits. Strength was a composite score of isometric strength tests for internal rotation, external rotation, and abduction. Pain was a composite score of visual analog scale measures during resisted break tests, active abduction, and functional activities. Function was measured with a functional assessment questionnaire. The visual analog scale used to measure pain with functional activities and the functional assessment questionnaire were also measured 2 months after the initiation of treatment. RESULTS: Subjects in both groups experienced significant decreases in pain and increases in function, but there was significantly more improvement in the manual therapy group compared to the exercise group. For example, pain in the manual therapy group was reduced from a pretreatment mean (+/- SD) of 575.8 (+/- 220.0) to a posttreatment mean of 174.4 (+/- 183.1). In contrast, pain in the exercise group was reduced from a pretreatment mean of 557.1 (+/- 237.2) to a posttreatment mean of 360.6 (+/- 272.3). Strength in the manual therapy group improved significantly while strength in the exercise group did not. CONCLUSION: Manual physical therapy applied by experienced physical therapists combined with supervised exercise in a brief clinical trial is better than exercise alone for increasing strength, decreasing pain, and improving function in patients with shoulder impingement syndrome.

Adult↗