Intrauterine instillation of diluted seminal plasma at oocyte pick-up does not increase the IVF pregnancy rate: a double-blind, placebo controlled, randomized study.

STUDY QUESTION Does intrauterine application of diluted seminal plasma (SP) at the time of ovum pick-up improve the pregnancy rate by ≥14% in IVF treatment? SUMMARY ANSWER Intrauterine instillation of diluted SP at the time of ovum pick-up is unlikely to increase the pregnancy rate by ≥14% in IVF. WHAT IS KNOWN ALREADY SP modulates endometrial function, and sexual intercourse around the time of embryo transfer has been suggested to increase the likelihood of pregnancy. A previous randomized double-blind pilot study demonstrated a strong trend towards increased pregnancy rates following the intracervical application of undiluted SP. As this study was not conclusive and as the finding could have been confounded by sexual intercourse, the intrauterine application of diluted SP was investigated in the present trial. STUDY DESIGN, SIZE, DURATION A single-centre, prospective, double-blind, placebo-controlled, randomized, superiority trial on women undergoing IVF was conducted from April 2007 until February 2012 at the University Department of Gynaecological Endocrinology and Reproductive Medicine, Heidelberg, Germany. PARTICIPANTS/MATERIALS, SETTING, METHODS The study was powered to detect an 14% increase in the clinical pregnancy rate and two sequential tests were planned using the Pocock spending function. At the first interim analysis, 279 women had been randomly assigned to intrauterine diluted SP (20% SP in saline from the patients' partner) (n = 138) or placebo (n = 141) at the time of ovum pick-up. MAIN RESULTS AND THE ROLE OF CHANCE The clinical pregnancy rate per randomized patient was 37/138 (26.8%) in the SP group and 41/141 (29.1%) in the placebo group (difference: -2.3%, 95% confidence interval of the difference: -12.7 to +8.2%; P = 0.69). The live birth rate per randomized patient was 28/138 (20.3%) in the SP group and 33/141 (23.4%) in the placebo group (difference: -3.1%, 95% confidence interval of the difference: -12.7 to +6.6%; P = 0.56). It was decided to terminate the trial due to futility at the first interim analysis, at a conditional power of 62%. LIMITATIONS, REASONS FOR CAUTION The confidence interval of the difference remains wide, thus clinically relevant differences cannot reliably be excluded based on this single study. WIDER IMPLICATIONS OF THE FINDINGS The results of this study cast doubt on the validity of the concept that SP increases endometrial receptivity and thus implantation in humans. STUDY FUNDING/COMPETING INTEREST(S) Funding was provided by the department's own research facilities. TRIAL REGISTRATION NUMBER DRKS00004615.

Acupuncture for post anaesthetic recovery and postoperative pain: study protocol for a randomised controlled trial.

BACKGROUND We report on the design and implementation of a study protocol entitled Acupuncture randomised trial for post anaesthetic recovery and postoperative pain - a pilot study (ACUARP) designed to investigate the effectiveness of acupuncture therapy performed in the perioperative period on post anaesthetic recovery and postoperative pain. METHODS/DESIGN The study is designed as a randomised controlled pilot trial with three arms and partial double blinding. We will compare (a) press needle acupuncture, (b) no treatment and (c) press plaster acupressure in a standardised anaesthetic setting. Seventy-five patients scheduled for laparoscopic surgery to the uterus or ovaries will be allocated randomly to one of the three trial arms. The total observation period will begin one day before surgery and end on the second postoperative day. Twelve press needles and press plasters are to be administered preoperatively at seven acupuncture points. The primary outcome measure will be time from extubation to 'ready for discharge' from the post anaesthesia care unit (in minutes). The 'ready for discharge' end point will be assessed using three different scores: the Aldrete score, the Post Anaesthetic Discharge Scoring System and an In-House score. Secondary outcome measures will comprise pre-, intra- and postoperative variables (which are anxiety, pain, nausea and vomiting, concomitant medication). DISCUSSION The results of this study will provide information on whether acupuncture may improve patient post anaesthetic recovery. Comparing acupuncture with acupressure will provide insight into potential therapeutic differences between invasive and non-invasive acupuncture techniques. TRIAL REGISTRATION NCT01816386 (First received: 28 October 2012).

Effect of standardized training on the reliability of the Cochrane risk of bias assessment tool: a study protocol

BACKGROUND The Cochrane risk of bias (RoB) tool has been widely embraced by the systematic review community, but several studies have reported that its reliability is low. We aim to investigate whether training of raters, including objective and standardized instructions on how to assess risk of bias, can improve the reliability of this tool. We describe the methods that will be used in this investigation and present an intensive standardized training package for risk of bias assessment that could be used by contributors to the Cochrane Collaboration and other reviewers. METHODS/DESIGN This is a pilot study. We will first perform a systematic literature review to identify randomized clinical trials (RCTs) that will be used for risk of bias assessment. Using the identified RCTs, we will then do a randomized experiment, where raters will be allocated to two different training schemes: minimal training and intensive standardized training. We will calculate the chance-corrected weighted Kappa with 95% confidence intervals to quantify within- and between-group Kappa agreement for each of the domains of the risk of bias tool. To calculate between-group Kappa agreement, we will use risk of bias assessments from pairs of raters after resolution of disagreements. Between-group Kappa agreement will quantify the agreement between the risk of bias assessment of raters in the training groups and the risk of bias assessment of experienced raters. To compare agreement of raters under different training conditions, we will calculate differences between Kappa values with 95% confidence intervals. DISCUSSION This study will investigate whether the reliability of the risk of bias tool can be improved by training raters using standardized instructions for risk of bias assessment. One group of inexperienced raters will receive intensive training on risk of bias assessment and the other will receive minimal training. By including a control group with minimal training, we will attempt to mimic what many review authors commonly have to do, that is-conduct risk of bias assessment in RCTs without much formal training or standardized instructions. If our results indicate that an intense standardized training does improve the reliability of the RoB tool, our study is likely to help improve the quality of risk of bias assessments, which is a central component of evidence synthesis.

Early bone apposition to hydrophilic and hydrophobic titanium implant surfaces: a histologic and histomorphometric study in minipigs.

OBJECTIVE The first objective of this pilot study was to evaluate the impact of the hydrophilicity on the early phases of osseointegration. The second objective was to compare two hydrophilic implant surfaces with different geometries, surface roughness, and technologies achieving hydrophilicity. MATERIAL AND METHODS Twelve weeks after extraction, all four quadrants of nine minipigs received three dental implants, alternating between hydrophilic microrough surfaces (INICELL and SLActive) and a conventional hydrophobic microrough surface. After 5, 10, and 15 days of submerged healing, ground sections were prepared and subjected to histologic and histomorphometric analysis. RESULTS The histologic analysis revealed a similar healing pattern among the hydrophilic and hydrophobic implant surfaces, with extensive bone formation occurring between day 5 and day 10. With BIC values of greater than 50% after 10 days, all examined surfaces indicated favorable osseointegration at this very early point in healing. At day 15, the mean new bone-to-implant contact (newBIC) of one hydrophilic surface (INICELL; 55.8 ± 14.4%) was slightly greater than that of the hydrophobic microrough surface (40.6 ± 20.2%). At day 10 and day 15, an overall of 21% of the implants had to be excluded from analysis due to inflammations primarily caused by surgical complications. CONCLUSION Substantial bone apposition occurs between day 5 and day 10. The data suggest that the hydrophilic surface can provoke a slight tendency toward increased bone apposition in minipigs after 15 days. A direct comparison of two hydrophilic surfaces with varying geometries is of limited relevance.

Virtual Patients in continuing medical education and residency training: a pilot project for acceptance analysis in the framework of a residency revision course in pediatrics.

AIM Virtual patients (VPs) are a one-of-a-kind e-learning resource, fostering clinical reasoning skills through clinical case examples. The combination with face-to-face teaching is important for their successful integration, which is referred to as "blended learning". So far little is known about the use of VPs in the field of continuing medical education and residency training. The pilot study presented here inquired the application of VPs in the framework of a pediatric residency revision course. METHODS Around 200 participants of a pediatric nephology lecture ('nephrotic and nephritic syndrome in children') were offered two VPs as a wrap-up session at the revision course of the German Society for Pediatrics and Adolescent Medicine (DGKJ) 2009 in Heidelberg, Germany. Using a web-based survey form, different aspects were evaluated concerning the learning experiences with VPs, the combination with the lecture, and the use of VPs for residency training in general. RESULTS N=40 evaluable survey forms were returned (approximately 21%). The return rate was impaired by a technical problem with the local Wi-Fi firewall. The participants perceived the work-up of the VPs as a worthwhile learning experience, with proper preparation for diagnosing and treating real patients with similar complaints. Case presentations, interactivity, and locally and timely independent repetitive practices were, in particular, pointed out. On being asked about the use of VPs in general for residency training, there was a distinct demand for more such offers. CONCLUSION VPs may reasonably complement existing learning activities in residency training.

[Pilot Project: Improved Lung Deposition via a New Nasal Inhalation Procedure].

INTRODUCTION Inhaled drugs can only be effective if they reach the middle and small airways. This study introduces a system that combines a trans-nasal application of aerosols with noninvasive pressure support ventilation. METHODS In a pilot study, 7 COPD patients with GOLD stages II and III inhaled a radiolabeled marker dissolved in water via a trans-nasal route. The mean aerosol particle size was 5.5 µm. Each patient took part in two inhalation sessions that included two application methods and were at least 70 hours apart. During the first session ("passive method"), the patient inhaled the aerosol through an open tube system. The second session ("active method") included pressure support ventilation during the inhalation process. A gamma camera and planar scintigraphy was used to determine the distribution of aerosol particles in the patient's body and lung. RESULTS The pressure supported inhalation ("active method") results in an increased aerosol lung deposition compared to the passive method. Above all, we could demonstrate deposition in the lung periphery with relatively large aerosol particles (5.5 µm). DISCUSSION The results prove that the combination of trans-nasal inhalation with noninvasive pressure support ventilation leads to significantly increased particle deposition in the lung.

Obesity and risk of multiple myeloma: A case-control study

Introduction. Several studies have reported a positive association of body mass index (BMI) with multiple myeloma; however, the period of adulthood where BMI is most important remains unclear. In addition, it is well known that body fat is associated with both sex-steroid hormone storage and with increasing insulin levels; therefore, it was hypothesized that the association between obesity and multiple myeloma may be attributed to increased aromatization of androgen in adipose tissue. Objective. The overall objective of this case-control study was to determine whether multiple myeloma cases had higher BMI and greater adult weight gain relative to healthy controls. In addition, we tested the hypothesis that hormone replacement therapy use among women will further increase the association between BMI and risk of multiple myeloma. This study used data from a pilot case-control study at M.D. Anderson Cancer Center (MDACC), entitled Etiology of multiple myeloma, directed by Dr. Sara Strom and Dr. Sergio Giralt. Methods. The pilot study recruited a total of 122 cases of histopathologically confirmed multiple myeloma from MDACC. Controls (n=183) were selected from a database of random digit dialing controls accrued in the Department of Epidemiology at MDACC and were frequency matched to the cases on age (±5 years), gender, and race/ethnicity. Demographic and risk factor information were obtained from all participants who completed a self-administered questionnaire. Items included in the questionnaire include demographic information, height and weight at age 25, 40 and current/diagnosis, medical history, family history of cancer, smoking and alcohol use. Statistical analysis. Initial descriptive analysis included Student's t-test and Pearson's chi-squared tests. Odds ratios and 95% confidence intervals were calculated to quantify the association between the variables of interest and multiple myeloma. A multivariable model will be developed using unconditional logistic regression. Results. MM cases were 1.79 times (95% CI=0.99-3.32) more likely to have been overweight or obese (BMI > 25 kg/m2) at age 25 relative to healthy controls after controlling for age, gender, race/ethnicty, education and family history of cancer. Being overweight or obese at age 40 was not significantly associated with mutliple myeloma risk (OR=1.42, 95% CI=0.86-2.34) nor was being overweight or obses at diagnosis (OR=1.43, 95% CI=0.78, 2.63). We observed a statistically significant 2-fold increased odds of multiple myeloma in individuals who gained more than 4.7 kg during between 25 and 40 years (OR=1.97, 95% CI=1.15-3.39). When assessing HRT as a modifier of the BMI and multiple myeloma association among women (N=123), no association between obesity and MM status was observed among women who have never used HRT (OR=0.60, 95% CI=0.23-1.61; n=73). Yet among women who have ever used HRT (n=50), being overweight or obese was associated with an increase in MM risk (OR=2. 93, 95% CI=0.81-10.6) after adjusting for age; however, the association was not statistically significant. Significance. This study provides further evidence that increased BMI increases the risk of multiple myeloma. Furthermore, among women, HRT use may modify risk of disease. ^

A feasibility study for assessing building occupants' indoor air quality expectations compared to nationally recognized standards

Indoor Air Quality (IAQ) can have significant implications for health, productivity, job performance, and operating cost. Professional experience in the field of indoor air quality suggests that high expectations (better than nationally established standards) (American Society of Heating, Refrigerating, and Air-conditioning Engineers (ASHRAE)) of workplace indoor air quality lead to increase air quality complaints. To determine whether there is a positive association between expectations and indoor air quality complaints, a one-time descriptive and analytical cross-sectional pilot study was conducted. Area Safety Liaisons (n = 330) at University of Texas Health Science Center – Houston were asked to answer a questionnaire regarding their expectations of four workplace indoor air quality indicators i.e., (temperature, relative humidity, carbon dioxide, and carbon monoxide) and if they experienced and reported indoor air quality problems. A chi-square test for independence was used to evaluate associations among the variables of interest. The response rate was 54% (n = 177). Results did not show significant associations between expectation and indoor air quality. However, a greater proportion of Area Safety Liaisons who expected indoor air quality indicators to be better than the established standard experienced greater indoor air quality problems. Similarly, a slightly higher proportion of Area Liaisons who expected indoor air quality indicators to be better than the standard reported greater indoor air quality complaints. ^ The findings indicated that a greater proportion of Area Safety Liaisons with high expectations (conditions that are beyond what is considered normal and acceptable by ASHRAE) experienced greater indoor air quality discomfort. This result suggests a positive association between high expectations and experienced and reported indoor air quality complaints. Future studies may be able to address whether the frequency of complaints and resulting investigations can be reduced through information and education about what are acceptable conditions.^

Dispensing activity in a community pharmacy-based repeat dispensing pilot project

Objective: To measure changes in dispensing activity in a UK repeat dispensing pilot study and to estimate any associated cost savings. Method: Patients were provided with two successive three-monthly repeat prescriptions containing all of the items on their "repeat medicines list" and valid at a study pharmacy. Pharmacists consulted with patients at the time of supply and completed a patient-monitoring form. Prescriptions with pricing data were returned by the UK Prescription Pricing Authority. These data were used to calculate dispensing activity, the cost of dispensed items and an estimate of cost savings on non-dispensed items. A retrospective identification of items prescribed during the six months prior to the project was used to provide a comparison with those dispensed during the project and thus a more realistic estimate of changes. Setting: 350 patients from two medical practices in a large English City, with inner city and suburban locations, and served by seven pharmacies. Key findings: There were methodological challenges in establishing a robust framework for calculating changes. Based on all of the items that patients could have obtained from their repeat list, 23.8% were not dispensed during the intervention period. A correction was then made to allow for a comparison with usage in the six months prior to the study. Based on the corrected data, there was an estimated 11.3% savings in drug costs compared with the pre-intervention period. There was a marked difference in changes between the two practices, the pharmacies and individual patients. The capitation-based remuneration method was acceptable to all but one of the community pharmacists. Conclusion: The repeat dispensing system reduced dispensing volume in comparison with the control period. A repeat dispensing system with a focus on patients' needs and their use of medicines might be cost neutral.

Innovation in teams : a qualitative and quantitative study of team behaviours

This thesis explores the processes of team innovation. It utilises two studies, an organisationally based pilot and an experimental study, to examine and identify aspects of teams' behaviours that are important for successful innovative outcome. The pilot study, based in two automotive manufacturers, involved the collection of team members' experiences through semi-structured interviews, and identified a number of factors that affected teams' innovative performance. These included: the application of ideative & dissemination processes; the importance of good team relationships, especially those of a more informal nature, in facilitating information and ideative processes; the role of external linkages in enhancing quality and radicality of innovations; and the potential attenuation of innovative ideas by time deadlines. This study revealed a number key team behaviours that may be important in successful innovation outcomes. These included; goal setting, idea generation and development, external contact, task and personal information exchange, leadership, positive feedback and resource deployment. These behaviours formed the basis of a coding system used in the second part of the research. Building on the results from the field based research, an experimental study was undertaken to examine the behavioural differences between three groups of sixteen teams undertaking innovative an task to produce an anti-drugs poster. They were randomly assigned to one of three innovation category conditions suggested by King and Anderson (1990), emergent, imported and imposed. These conditions determined the teams level of access to additional information on previously successful campaigns and the degree of freedom they had with regarding to the design of the poster. In addition, a further experimental condition was imposed on half of the teams per category which involved a formal time deadline for task completion. The teams were video taped for the duration of their innovation and their behaviours analysed and coded in five main aspects including; ideation, external focus, goal setting, interpersonal, directive and resource related activities. A panel of experts, utilising five scales developed from West and Anderson's (1996) innovation outcome measures, assessed the teams' outputs. ANOVAs and repeated measure ANOVAs were deployed to identify whether there were significant differences between the different conditions. The results indicated that there were some behavioural differences between the categories and that over the duration of the task behavioural changes were identified. The results, however, revealed a complex picture and suggested limited support for three distinctive innovation categories. There were many differences in behaviours, but rarely between more than two of the categories. A main finding was the impact that different levels of constraint had in changing teams' focus of attention. For example, emergent teams were found to use both their own team and external resources, whilst those who could import information about other successful campaigns were likely to concentrate outside the team and pay limited attention to the internal resources available within the team. In contrast, those operating under task constraints with aspects of the task imposed onto them were more likely to attend to internal team resources and pay limited attention to the external world. As indicated by the earlier field study, time deadlines did significantly change teams' behaviour, reducing ideative and information exchange behaviours. The model shows an important behavioural progression related to innovate teams. This progression involved the teams' openness initially to external sources, and then to the intra-team environment. Premature closure on the final idea before their mid-point was found to have a detrimental impact on team's innovation. Ideative behaviour per se was not significant for innovation outcome, instead the development of intra-team support and trust emerged as crucial. Analysis of variance revealed some limited differentiation between the behaviours of teams operating under the aforementioned three innovation categories. There were also distinct detrimental differences in the behaviour of those operating under a time deadline. Overall, the study identified the complex interrelationships of team behaviours and outcomes, and between teams and their context.

A study of the role of the community pharmacist in responding to symptons

Factors affecting the current role of the community pharmacist in responding to symptoms are investigated. Communication and collaboration with general medical practitioners (GPs), and the competency of pharmacists and counter assistants to perform the role of responding to symptoms, are examined. A national survey of GPs, conducted by postal questionnaire, explores attitudes towards the role of the community pharmacist in the treatment of patients' symptoms, and towards future extension of such a role. A majority (over 90%) of respondents thought that the counter prescribing activities of the pharmacist should be maintained or increased. Doctors supported treatment of most minor illnesses by pharmacists, but there was relatively little support for the deregulation of selected Prescription Only Medicines. Three quarters of respondents were in favour of joint educational meetings for pharmacists and doctors. Most GPs (85%) expressed support for a formal referral route from pharmacists to doctors, using a "notification card". A pilot study of the use of a notification card was conducted . Two thirds of the patients who were advised to see their doctor by the pharmacist subsequently did so. In most cases , the GP rated the patients' symptoms " significant" and the card "helpful". Pharmacists' and counter assistants' competency in responding to symptoms was assessed by a programme of pharmacy visits, where previously-defined symptoms were presented. Some pharmacists' questioning skills were found to be inadequate, and their knowledge not sufficiently current. Counter assistants asked fewer and less appropriate questions than did pharmacists, and assistants ' knowledge base was shown to be inadequate. Recommendations are made in relation to the education and training of pharmacists and counter assistants in responding to symptoms .

A study of the aerodynamic characteristics of captor hoods in local exhaust ventilation systems

The research objectives were:- 1.To review the literature to establish the factors which have traditionally been regarded as most crucial to the design of effectlve exhaust ventilation systems. 2. To design, construct, install and calibrate a wind tunnel. 3. To develop procedures for air velocity measurement followed by a comprehensive programme of aerodvnamic data collection and data analysis for a variety of conditions. The major research findings were:- a) The literature in the subject is inadequate. There is a particular need for a much greater understanding of the aerodynamics of the suction flow field. b) The discrepancies between the experimentally observed centre-line velocities and those predicted by conventional formulae are unacceptably large. c) There was little agreement between theoretically calculated and observed velocities in the suction zone of captor hoods. d) Improved empirical formulae for the prediction of centre-line velocity applicable to the classical geometrically shaped suction openings and the flanged condition could be (and were) derived. Further analysis of data revealed that: - i) Point velocity is directly proportional to the suction. flow rate and the ratio of the point velocity to the average face velocity is constant. ii) Both shape, and size of the suction opening are significant factors as the coordinates of their points govern the extent of the effect of the suction flow field. iii) The hypothetical ellipsoidal potential function and hyperbolic streamlines were found experimentally to be correct. iv) The effect of guide plates depends on the size, shape and the angle of fitting. The effect was to very approximately double the suction velocity but the exact effect is difficult to predict. v) The axially symmetric openings produce practically symmetric flow fields. Similarity of connection pieces between the suction opening and the main duct in each case is essential in order to induce a similar suction flow field. Additionally a pilot study was made in which an artificial extraneous air flow was created, measured and its interaction with the suction flow field measured and represented graphically.

Electronic commerce adoption:a study of business-to-business practice in Saudi Arabia

Electronic commerce (e-commerce) has become an increasingly important initiative among organisations. The factors affecting adoption decisions have been well-documented, but there is a paucity of empirical studies that examine the adoption of e-commerce in developing economies in the Arab world. The aim of this study is to provide insights into the salient e-commerce adoption issues by focusing on Saudi Arabian businesses. Based on the Technology-Organisational-Environmental framework, an integrated research model was developed that explains the relative influence of 19 known determinants. A measurement scale was developed from prior empirical studies and revised based on feedback from the pilot study. Non-interactive adoption, interactive adoption and stabilisation of e-commerce adoption were empirically investigated using survey data collected from Saudi manufacturing and service companies. Multiple discriminant function analysis (MDFA) was used to analyse the data and research hypotheses. The analysis demonstrates that (1) regarding the non-interactive adoption of e-commerce, IT readiness, management team support, learning orientation, strategic orientation, pressure from business partner, regulatory and legal environment, technology consultants‘ participation and economic downturn are the most important factors, (2) when e-commerce interactive adoption is investigated, IT readiness, management team support, regulatory environment and technology consultants‘ participation emerge as the strongest drivers, (3) pressure from customers may not have much effect on the non-interactive adoption of e-commerce by companies, but does significantly influence the stabilisation of e-commerce use by firms, and (4) Saudi Arabia has a strong ICT infrastructure for supporting e-commerce practices. Taken together, these findings on the multi-dimensionality of e-commerce adoption show that non-interactive adoption, interactive adoption and stabilisation of e-commerce are not only different measures of e-commerce adoption, but also have different determinants. Findings from this study may be valuable for both policy and practice as it can offer a substantial understanding of the factors that enhance the widespread use of B2B e-commerce. Also, the integrated model provides a more comprehensive explanation of e-commerce adoption in organisations and could serve as a foundation for future research on information systems.

Making mole-hills out of mountains:Peer Mentoring in Engineering education - A case-study

Based on the emergent findings of a pilot study which examined the issues around introducing Peer Mentoring into an Engineering School, this paper, which is very much a 'work in progress', describes and discusses results from the first year of what will be a three year exploratory study. Focusing on three distinctive concepts integral to the student experience, Relationships, Variety and Synergy, the study follows an Action Research Design in that it aims to find a realistic and workable solution to issues of attrition within the Engineering School in which the Project and Study are set. Starting with the research question "Does Peer Mentoring improve engineering students' transition into university?"', the Pilot Project and Study will run for three years, each year building on the lessons of the previous year.

Understanding and improving the manufacturing and changeover process in Saudi Arabian business - a multiple case study approach

The importance of the changeover process in the manufacturing industry is becoming widely recognised. Changeover is a complete process of changing between the manufacture of one product to manufacture of an alternative product until specified production and quality rates are reached. The initiatives to improve changeover exist in industry, as better changeover process typically contribute to improved quality performance. A high-quality and reliable changeover process can be achieved through implementation of continuous or radical improvements. This research examines the changeover process of Saudi Arabian manufacturing firms because Saudi Arabia’s government is focused on the expansion of GDP and increasing the number of export manufacturing firms. Furthermore, it is encouraging foreign manufacturing firms to invest within Saudi Arabia. These initiatives, therefore, require that Saudi manufacturing businesses develop the changeover practice in order to compete in the market and achieve the government’s objectives. Therefore, the aim of this research is to discover the current status of changeover process implementation in Saudi Arabian manufacturing businesses. To achieve this aim, the main objective of this research is to develop a conceptual model to understand and examine the effectiveness of the changeover process within Saudi Arabian manufacturing firms, facilitating identification of those activities that affect the reliability and high-quality of the process. In order to provide a comprehensive understanding of this area, this research first explores the concept of quality management and its relationship to firm performance and the performance of manufacturing changeover. An extensive body of literature was reviewed on the subject of lean manufacturing and changeover practice. A research conceptual model was identified based on this review, and focus was on providing high-quality and reliable manufacturing changeover processes during set-up in a dynamic environment. Exploratory research was conducted in sample Saudi manufacturing firms to understand the features of the changeover process within the manufacturing sector, and as a basis for modifying the proposed conceptual model. Qualitative research was employed in the study with semi-structured interviews, direct observations and documentation in order to understand the real situation such as actual daily practice and current status of changeover process in the field. The research instrument, the Changeover Effectiveness Assessment Tool (CEAT) was developed to evaluate changeover practices. A pilot study was conducted by examining the CEAT, proposed for the main research. Consequently, the conceptual model was modified and CEAT was improved in response to the pilot study findings. Case studies have been conducted within eight Saudi manufacturing businesses. These case studies assessed the implementation of manufacturing changeover practice in the lighting and medical products sectors. These two sectors were selected based on their operation strategy which was batch production as well as the fact that they fulfilled the research sampling strategy. The outcomes of the research improved the conceptual model, ultimately to facilitate the firms’ adoption and rapid implementation of a high-quality and reliability changeover during the set-up process. The main finding of this research is that Quality’s factors were considering the lowest levels comparing to the other factors which are People, Process and Infrastructure. This research contributes to enable Saudi businesses to implement the changeover process by adopting the conceptual model. In addition, the guidelines for facilitating implementation were provided in this thesis. Therefore, this research provides insight to enable the Saudi manufacturing industry to be more responsive to rapidly changing customer demands.