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At least 1,027 records · Page 57Linked to original sources
PubMed2001

Economic analysis of amifostine as adjunctive support for patients with advanced head and neck cancer: preliminary results from a randomized phase II clinical trial from Germany.

In a randomized phase II trial in Germany, we investigated the clinical and economic impact of amifostine protection against the hematological and oral toxicities of carboplatin administered concurrently with standard fractions of radiotherapy. 28 patients with squamous cell carcinomas of the head and neck received adjunctive or primary radiotherapy (5 days per week with daily fractions of 2 Gy, up to a total dose of 60 Gy) in conjunction with carboplatin (70 mg/m2) on days 1-5 and days 21-26. All patients received radiation encompassing at least 75% of the major salivary glands. Patients were randomized to receive radiation and carboplatin (RCT) alone or RCT preceded by rapid infusion of amifostine (500 mg) on days carboplatin was administered. The 14 patients who received amifostine, in comparison to 14 patients in the control arm, had significantly fewer episodes of grade 3 or 4 thrombocytopenia (p = 0.001), mucositis (p = 0.001), and xerostomia (p = 0.001). The patients receiving amifostine accrued significantly lower supportive care costs for resources related to infection ($241 vs. $1,275, p < 0.01), red blood cell and platelet support ($286 vs. $1,276 p = 0.06) alimentation ($343 vs. $894, p = .01), and hospitalization ($286 vs. $2,429, p < 0.01). Overall, including the costs of amifostine, mean per patient supportive care costs were $4,401 for the amifostine group and $5,873 (p = .02) for the control group. Our results from a randomized phase II trial indicate that selective cytoprotection with amifostine potentially offers clinical and economic benefits in patients with advanced head and neck cancer receiving radiochemotherapy. Additional economic studies alongside randomized phase III trials and from other countries are needed.

Amifostine↗
PubMed2004

Complementary and alternative medicines (CAM) in the management of asthma: an examination of the evidence.

Although individuals are using Complementary and Alternative Medical (CAM) therapies to help manage their asthma, there is no clear direction in the current guidelines for the use of CAM in asthma. This literature review undertakes to determine the current science regarding the use of CAM in asthma management. Electronic literature searched all EBM Reviews, Medline, OVID full text, and PubMed and National Complementary and Alternative Medication databases for Randomised Controlled Trials (RCT) published in English between 1997 and 2002 with keywords "asthma" and "complementary medicine" or "complementary therapy" or "alternative medicine" or "alternative therapy." Abstracts (N=197) were reviewed for inclusion in the review and duplicates discarded (N=65). Abstracts of non-RCT studies, review articles, and surveys were also discarded (N=66). Abstracts discussing environmental control measures and pharmaceutical alternatives to steroid therapy were discarded (N=9). The 15 final studies were grouped within three categories: mind-body and relaxation, manual therapies, and diet and reviewed for statistical and clinical significance, suggesting some CAM therapies have shown minimally significant improvements in asthma quality of life (breathing exercises) or pulmonary function (relaxation) and immune function (relaxation and acupuncture) in select asthma populations. Although CAM therapy is being used in the management of asthma, these 15 studies show a tendency to little or no significant difference between placebo or sham therapy. This may be due, in part, to the enhanced placebo effect of sham therapies used as control and the small size of most studies. Although the changes in the immune function seen in two studies are provocative, these changes did not translate to changes in lung function. More research is needed to assist in determining the efficacy of CAM therapies in asthma management.

Acupuncture Therapy↗
PubMed2003

Reporting of clinical details in randomized controlled trials of acupuncture for the treatment of migraine/headaches and nausea/vomiting.

OBJECTIVES: The main purpose of this study was to investigate the degree of reporting of clinical details in a selected sample of 30 randomized control trials (RCT) on acupuncture efficacy for the treatment of migraine/headaches (n = 11) and for nausea/vomiting (n = 19). Additional goals included the assessment of the quality of randomization of the trials, and the assessment of the degree of reporting of information about the outcome measures used in each trial. METHODS: A checklist of 50 clinical details selected on the basis of a previous survey was used to evaluate the degree of reporting of information about patients, practitioners, diagnosis, and acupuncture treatments presented in each RCT. The likelihood of bias in the randomization process was assessed using a previously validated scale. Information about reliability/validity and clinical significance of the outcome measures used in each trial was assessed in terms of fully, partially, or not reported, with no attempt to evaluate their quality or appropriateness. RESULTS: In this sample of RCTs an average of 38.7% of important clinical details per trial were either fully or partially reported by researchers, the lowest being 26.4% for the migraine/headaches group. Studies with better quality of randomization were not more likely to report important clinical details. Only five studies (16.7%) provided information about reliability and validity of the outcome measures used, and only four studies (13.3%), all from the migraines/headache group, discussed the clinical significance of the outcome measures selected. CONCLUSIONS: In this sample of 30 RCTs of acupuncture efficacy for the treatment of migraines/headache and nausea/vomiting, researchers neglected to report adequately on important clinical details, and often did not discuss the reliability, validity, and clinical significance of the outcome measures used in the trials, thus rendering potential readers of the articles unable to critically appraise them from a clinical standpoint. In addition, the fact that the quality of randomization of the trials was totally unrelated to the degree of reporting of clinical details renders potential reviewers of these studies unable to establish valid conclusions about acupuncture efficacy based on the general quality of the methodological design. In the future, all areas of clinical acupuncture research need to be reviewed in a similar manner, and recommendations about proper reporting of important clinical details and proper discussion of the validity, reliability, and clinical significance of the outcome measures used in each trial should be made. Only then could this research be used to generate meaningful evidence-based recommendations for the contemporary practice of acupuncture.

Acupuncture Therapy↗
PubMed2003

Efficacy of massage therapy in chronic pain: a pragmatic randomized trial.

BACKGROUND: Although classic massage is used widely in Germany and elsewhere for treating chronic pain conditions, there are no randomized controlled trials (RCT). DESIGN: Pragmatic RCT of classic massage compared to standard medical care (SMC) in chronic pain conditions of back, neck, shoulders, head and limbs. OUTCOME MEASURE: Pain rating (nine-point Likert-scale; predefined main outcome criterion) at pretreatment, post-treatment, and 3 month follow-up, as well as pain adjective list, depression, anxiety, mood, and body concept. RESULTS: Because of political and organizational problems, only 29 patients were randomized, 19 to receive massage, 10 to SMC. Pain improved significantly in both groups, but only in the massage group was it still significantly improved at follow-up. Depression and anxiety were improved significantly by both treatments, yet only in the massage group maintained at follow-up. CONCLUSION: Despite its limitation resulting from problems with numbers and randomization this study shows that massage can be at least as effective as SMC in chronic pain syndromes. Relative changes are equal, but tend to last longer and to generalize more into psychologic domains. Because this is a pilot study, the results need replication, but our experiences might be useful for other researchers.

Adult↗
PubMed2004

Appropriate methods to assess the effectiveness and efficacy of treatments or interventions to control cancer pain.

Pain is common in cancer patients. To ensure optimal pain management efficacy and effectiveness of new drugs and treatments have to be investigated in clinical trials. Efficacy trials such as randomised controlled trials (RCT) are experimental studies and estimate the maximum potential benefit to be derived from an intervention in ideal circumstances and under a controlled environment. RCTs are the only trial design to establish causal effects. A crossover study is a special type of RCT where patients serve as own controls. In efficacy studies the intervention and the control group should be as homogeneous as possible, confounding variables are controlled, bias is reduced, internal validity is high whereas external validity is low. Studies looking at effectiveness assess clinical practice and reflect real life circumstances. They rely high on external validity at the expense of careful controls, the study population is heterogeneous, confounding variables are examined. Cohort studies follow a group or groups of individuals with a common characteristic over a period of time to measure outcomes. Case-control studies start with the outcome and compare the characteristics of two groups of interest, those with the outcome and those without to identify factors which occur more or less often in the poor outcome group. Definition of outcome criteria is crucial both for efficacy and effectiveness studies and is often a primary problem. All clinical studies must use valid and reliable outcome measures.

Cross-Over Studies↗
PubMed2006

RNA interference from multimeric shRNAs generated by rolling circle transcription.

Methods most commonly used for producing small interfering RNAs (siRNAs) or short hairpin RNAs (shRNAs) are chemical synthesis and intracellular expression from engineered vectors. For shRNAs, chemical synthesis is very costly and construction of vectors is laborious. Synthesis by phage RNA polymerases from their natural promoters results in a 5 -terminal triphosphate that can trigger an interferon (IFN) response. Moreover, due to the requirement of phage promoters for 5 - GPuPuPu sequences for transcription initiation, shRNA transcripts may have extra 5 -nucleotides that can constrain the sequences that can be targeted. Also, the 3 ends may have an additional n + 1 nucleotide not encoded by the template. Here we present a novel approach for synthesizing functional shRNAs via rolling circle transcription (RCT) of small (approximately 70 nt) single-stranded DNA circles using T7 RNA polymerase, which avoids these issues. Due to internal pairing, these circles are dumbbell-shaped. RCT produces large transcripts (>10 kb in length) consisting of multimers (>150 copies) of shRNAs in the absence of promoter, terminator, or primer sequences. Dumbbells targeting red fluorescent protein (DsRed), human tumor necrosis factor-alpha (TNF-alpha) and hepatitis C virus (HCV) internal ribosome entry site (IRES) were prepared and transcribed. The resulting long transcripts are substrates for Dicer. When introduced into 293FT and Huh7 cells, the multimeric transcripts inhibited their target genes at levels similar to an equivalent mass of monomeric shRNAs, indicating that they can enter the RNAi pathway. Thus, rolling circle transcription of small DNA dumbbells provides a new source of biologically active interfering RNA.

Base Sequence↗
PubMed2005

Folic acid supplementation and the occurrence of congenital heart defects, orofacial clefts, multiple births, and miscarriage.

Key research findings relative to the question of whether maternal use of folic acid before and during pregnancy reduces the chance that offspring will be born with a congenital heart defect or an orofacial cleft are reviewed in this paper. Observational studies in general support an association between maternal use of multivitamins containing folic acid and a reduction in the occurrence of congenital heart defects and orofacial clefts. Results from one randomized controlled trial (RCT) provide the strongest evidence that multivitamins prevent congenital heart defects, but this RCT did not provide evidence that multivitamins prevent orofacial clefts. In addition, most observational and interventional studies are not designed to detect an independent effect from folic acid. Early studies suggested that periconceptional multivitamin use was associated with an increased occurrence of both miscarriages and multiple births, which has resulted in a great deal of controversy about the safety of folic acid use during pregnancy. We also review reports that were designed to answer these questions with more definitive data. When more substantial evidence about the effect of periconceptional folic acid on the occurrence of congenital heart defects and orofacial clefts is reported, we will have additional support for promoting folic acid intervention programs. All women capable of becoming pregnant should continue to consume 400 mug/d of folic acid in addition to a healthy diet as advised.

Abortion, Spontaneous↗
PubMed1995

Evaluating primary care follow-up of breast cancer: methods and preliminary results of three studies.

OBJECTIVE: To evaluate a primary care centred system of routine follow-up of women with breast cancer in remission. DESIGN, PATIENTS AND OUTCOME MEASURES: Three related studies are reported: 1) A randomized controlled trial (RCT) involving 296 women with breast cancer in remission (stage I, II, or III) all receiving routine follow-up at two district general hospitals in England. Women in the control group received follow-up in hospital clinics according to the usual practice. Women in the experimental group received follow-up from their own general practitioners (GP), and were referred back to hospital clinics if any breast cancer related problems developed. The main outcome of the trial was 'diagnostic delay': the time from the first presentation of signs or symptoms suggestive of recurrence to the time that recurrence was diagnosed. 2) A prospective descriptive study of a cohort of 141 women who were eligible for the trial, but who declined to participate. 3) A national survey of 376 specialists in breast cancer, and a survey of 226 general practitioners of the patients eligible for the RCT described above, to determine their views on follow-up of breast cancer in remission. RESULTS: 1) The randomized trial to evaluate primary care follow-up of breast cancer in remission has been successfully conducted and final results are pending. 2) Patients who were eligible but declined to participate in the trial were significantly older than participants (mean age 64.3 years compared with 60.7 years; difference 3.6 years; 95% confidence interval 0.53; 6.59). The two groups were similar in clinical characteristics and quality of life. 3) The majority of specialists and GPs preferred a system of routine follow-up which was primarily provided by their own professional group. CONCLUSIONS: A general practice centred system of routine follow-up of women with breast cancer in remission is acceptable to both patients and general practitioners. Final results of a randomized trial evaluating quality of care and quality of life outcome measures are pending.

Aged↗
PubMed1998

A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations.

In a qualitative systematic review, we have evaluated randomized controlled trials (RCT) of incisional local anaesthesia compared with placebo or no treatment in the control of postoperative pain after open abdominal operations. Twenty-six studies with data from 1211 patients were considered appropriate for analysis. Five RCT considered inguinal herniotomy, four hysterectomy, eight cholecystectomy and nine studies a variety of surgical procedures. Outcome measures were pain scores, supplementary analgesics and time to first analgesic request. Efficacy was estimated by significant difference (P < 0.05), as reported in the original investigation. All studies of herniotomy showed a 2-7-h duration of clinically relevant improved pain relief. Results of hysterectomy studies were inconclusive, with two being negative. Five of the cholecystectomy studies showed significant differences but questionable clinical importance and validity in three. In various other procedures results were inconsistent and in some of minor clinical importance. Except for herniotomy, there was a lack of evidence for effect of incisional local anaesthesia on postoperative pain and further standardized studies are needed before recommendations can be made.

Abdomen↗
PubMed2005

Guest editorial: what do prospective randomized clinical trials tell us about the treatment of class II malocclusions? A personal viewpoint.

The prospective randomized clinical trial (RCT) is seen by many to be the 'gold standard' for analysing treatment outcome and the only valid source of clinical data. In orthodontics, most RCTs have been designed to resolve the controversy surrounding the ability of functional appliances to significantly modify dentofacial growth. Given the variability in the timing, magnitude and duration of pubertal dentofacial growth, differing levels of motivation and patient compliance, the inherent inaccuracy of cephalometry and the questionable validity of the measurements themselves used to quantitate change, it is not surprising that the conclusions have not been as clear-cut as anticipated. Unlike a laboratory experiment, in which it is possible to limit the differences between experimental and control groups to the single factor being investigated, in a clinical trial an orthodontic appliance is just one of several variables affecting the outcome. Furthermore, RCTs are expensive and time-consuming; by the time the end-point of the study has been reached, the appliance may no longer be in widespread use, the fate of more than one recent well-publicized RCT. What RCTs have shown is that functional appliances such as the Herbst and twin block, based on the principle of 'jumping the bite', are more effective at modifying dentofacial growth and reducing overjets than headgear and more passive appliances such as the Andresen activator and its variants. However, if one asks whether RCTs have achieved their objective, or provided knowledge not previously available from retrospective studies or animal experimentation, then the answer would have to be no; it is also hard to justify the cost. What is particularly interesting is that knowledge based on years of clinical experience has been disregarded and then announced as if it was something completely new.

Cephalometry↗
PubMed1999

Individuals with low back pain: how do they view physical activity?

BACKGROUND: Recent guidelines for those with acute low back pain have advocated early resumption of normal activity and increased physical activity. Little is known about the relationship between low back pain and physical activity, and on the impact of that relationship on the promotion of increased levels of physical activity within a general practice population. OBJECTIVES: We aimed to explore associations between factors that influence changes in physical activity and the way individuals perceive and behave with their low back pain, and the impact of those perceptions and behaviour on physical activity. METHODS: Twenty-seven informants were chosen using a purposive sample from a larger group of individuals who, because of their low back trouble, had been referred by their GPs to a community-based, single-blind, randomized controlled trial (RCT) at the University of York, which is evaluating the effectiveness and cost-effectiveness of a progressive exercise programme. Fifty-four interviews were conducted with this subgroup of the RCT; four informants were interviewed once, 19 twice and four of them three times. Interviews were transcribed and analysed using manual and computer-aided approaches. RESULTS: Physical activity was perceived as (i) activities of daily living, (ii) activities causing breathlessness that they went out of the way to do and (iii) more competitive-type activity. The avoidance of physical activity and fear of pain returning were the two main factors directly associated with informants' backs and changes in physical activity. These two factors hindered increases in physical activity, even though the majority of informants believed strongly that being physically active helped ease their low back pain. CONCLUSIONS: When advocating that individuals with acute low back pain return to or increase physical activity, it is important that clinicians identify avoidance of physical activity and/or fear of pain at the earliest stage in order to tailor advice and reassurance appropriately. If avoidance of activity and fear of pain is identified and clinicians want to encourage patients to take up and sustain increased physical activity, they should explore issues of fear of pain, and avoidance of and confidence to do physical activities, in addition to other factors influencing physical activity.

Adult↗
PubMed2005

PubMed perspective of family medicine research: where does it stand?

OBJECTIVE: The aim of this study was to obtain a view of family medicine research by analyzing PubMed citations from 1960-2003. METHOD: Family practice (FP) citations in PubMed from 1960 to 2003 were downloaded in MEDLINE format. This was written into relation database using 'PubMed Grabber/Analyzer' software developed at University of Kelaniya, Sri Lanka. Search Query Language (SQL) and online PubMed queries were used for further analysis. RESULTS: There were 50288 FP citations from 80 countries. Of these, 33712 (67%) citations were from 15 FP journals. United Kingdom (18760), United States (13584), Australia (3262), Canada (1848), Germany-west (1340) were the five countries which had the most citations and 22 countries had less than 5 citations. Van Weel C (118), Geyman JP (116), Olesen F (87), Jones R (83) and Knottnerus JA (82) were numerically, the top five authors. Only 921 authors had more than 10 citations and the vast majority of authors had only one citation. Letters (5121), review (2715), editorial (2259), randomized controlled trials-RCT (1585) and Meta-analysis (44) were the top publication types. 40 citations found under 'qualitative research'. Discussion. The relatively few PubMed FP citations (50288) are by a small number of academics in developed countries. Citations showed an upsurge from the mid 1980s to the late 1990's but reached a plateau in the new millennium. Compared to PubMed citations from 1960-2003 in other specialties such as 2737655 for public health, 1151194 for cardiology & cardiovascular diseases and 318538 for medical informatics, the 50288 FP citations were paltry. Paucity of RCT (1585) and meta-analysis (44) was noted. The low 'qualitative research' citations (44) could have been due to the late introduction of the MeSH concept in 2003. CONCLUSIONS: Priority should be given to increase FP research and also to ensure the indexing of FP journals that are not currently indexed in PubMed. Efforts to increase citations in Medline may not give the desired results because of low priority given primary care specialties such as family medicine in the USA. Alternative solution of a separate bibliographic database for FP similar to PsycInfo may be too costly.

Family Practice↗
PubMed1997

A systematic review of the evidence for hypodermoclysis to treat dehydration in older people.

BACKGROUND: The purpose of the study was to evaluate the evidence supporting the use of hypodermoclysis (i.e., subcutaneous infusion of fluids) to treat dehydrated elderly patients, and to discuss clinical applications of this mode of therapy in the long-term care setting. METHOD: Articles reporting the use of hypodermoclysis were identified using a systematic MEDLINE search between January 1966 and May 1996. Articles were included in our sample if they contained original patient data that evaluated either the efficacy or adverse effects associated with the use of subcutaneous infusions to treat dehydration in adults, whether hyaluronidase was required to facilitate the absorption of subcutaneous fluid, or if potassium could be added to the solution. RESULTS: Eighteen articles met the inclusion criteria. Since we hypothesized that adverse effects associated with hypodermoclysis may have been related largely to the use of nonelectrolyte or hypertonic solutions, the studies were evaluated according to the type of fluid administered. Six hundred and eighty-five patients were described in 13 studies evaluating the efficacy and toxicity of subcutaneously administered fluid. Four studies evaluated hypodermoclysis using electrolyte-containing solutions in 25 patients. Two of these were randomized control trials (RCT) that compared hypodermoclysis to intravenous therapy. Both reported similar absorption of fluids. In the single RCT that evaluated adverse effects, 4 of 17 patients receiving hypodermoclysis reported minor side effects similar to those reported with intravenous therapy. Adverse effects were more severe when electrolyte-free or hypertonic solutions were evaluated. Of the 639 patients who may have received electrolyte-free solutions, 16 patients (2.5%) reported adverse effects, 8 of which were severe. Both patients reported to have received hypertonic solutions noted adverse effects, one of which was severe. The use of hyaluronidase to facilitate absorption was evaluated in 74 patients. These studies suggest that hyaluronidase improves the speed of fluid absorption but may not change the patient's comfort level. A single case report of 350 subcutaneous infusions in 67 patients investigated the administration of up to 34 mmol/L of potassium chloride (KCl) by hypodermoclysis. The only adverse reaction observed was discomfort at the infusion site. CONCLUSIONS: Hypodermoclysis can be used to most safely provide fluids when electrolyte-containing fluids are administered. Hypodermoclysis may have fallen into disuse because of reports of severe adverse reactions related to infusions of electrolyte-free or hypertonic solutions that would likely be considered inappropriate today. Whether or not hyaluronidase is required to promote subcutaneous fluid absorption remains unresolved. Limited evidence suggests that potassium chloride may, with caution, be safely added to subcutaneous infusions. The majority of the available studies evaluating hypodermoclysis are of poor quality. Because of the tremendous potential benefits of administering fluid subcutaneously, there is a need for good quality studies to evaluate the efficacy of hypodermoclysis.

Aged↗
PubMed2005

Training professionals to engage with and promote self-management.

We have set out to investigate an approach to improve patients' ability to self-manage chronic illness. For effective health care in chronic disease, we believe patients need to work in partnership with their doctor; patient-centred consultations are one way to achieve this. This report describes our experience of training specialists in gastroenterology to consult in a patient-centred style as part of a complex self-management intervention in a randomized controlled trial (RCT) involving 700 patients with established inflammatory bowel disease (IBD) attending outpatient clinics. The training session aimed to provide specialists from nine randomly selected intervention sites with the basic skills to carry out the intervention. The training lasted 2 hours, and included background on the research and intervention, a demonstration video, role-play, and video-feedback training. The main findings of the RCT are presented (service use, enablement and satisfaction), and discussed in the light of the views of consultants and patients on the experience of putting the training into practice. The findings of our study confirm and highlight the value of training in patient-centred communication and its potential for promoting self-management effects; the training proved effective in enabling consultants in gastroenterology to establish guided self-management in patients with IBD.

Adolescent↗
PubMed2006

Meeting the challenges of implementing process evaluation within randomized controlled trials: the example of ASSIST (A Stop Smoking in Schools Trial).

It is increasingly argued that the effectiveness of health promotion interventions should be measured to inform policy and practice. The randomized controlled trial (RCT) continues to be regarded as the 'gold standard' of health services research but health promotion practitioners have raised concerns about the RCT's appropriateness for evaluating their work. A preferred model is currently the pragmatic trial, measuring effectiveness under 'routine' conditions, incorporating a process evaluation to examine context, implementation and receipt. This model was chosen by A Stop Smoking in Schools Trial (ASSIST) to evaluate an intervention in which influential Year 8 students (12-13 years old) were trained to encourage non-smoking behaviour through informal conversations with their peers. Outcome data show that the intervention was effective in reducing smoking levels in intervention schools compared with control schools. In this paper we describe the extensive process evaluation embedded within the trial and, rather than focusing on resultant data, we consider the potential for such detailed examination of process to affect the intervention's delivery, receipt and outcome evaluation. We describe how some acknowledged challenges were addressed within ASSIST, which have relevance for future similar trials: Hawthorne effects, overlapping roles within the team and distinguishing between the intervention and its evaluation.

Adolescent↗
PubMed2006

A randomized control trial of Internet-delivered HIV prevention targeting rural MSM.

The Internet may be important for delivering human immunodeficiency virus (HIV) risk reduction to men who have sex with men (MSM) in rural areas. This randomized control trial (RCT) tested the acceptability and efficacy of an Internet-delivered HIV risk-reduction intervention. Two modules include a conversation between an HIV-negative man and an HIV-positive man, with interactive graphics. Ninety men were randomly assigned to intervention or wait-list control and 79% completed the study. An 'intent-to-treat' model was used. HIV/acquired immune deficiency syndrome (AIDS) knowledge, self-efficacy and outcome expectancies increased after participating in the intervention, and changes were maintained at 1-week follow-up. Participants said they would participate again. This RCT provides support for the acceptability and efficacy of the Internet for delivering HIV prevention messages to rural MSM.

Adolescent↗
PubMed2006

Recruitment and retention of Latinos in a primary care-based physical activity and diet trial: The Resources for Health study.

Mandates to include women and minority populations in research have heightened the need to identify successful recruitment strategies. This paper describes the recruitment and retention strategies used as part of a randomized controlled trial (RCT) of a physical activity and dietary intervention targeting low-income, predominantly Latino patients in a primary health care clinic. Data on the recruitment and retention rates and the representativeness of participants are presented. Strategies included hiring bilingual staff, translating and culturally adapting intervention materials and soliciting ongoing consultation from patients, clinicians and organizations providing services to the Latino community. The primary recruitment procedure involved letters from physicians followed by phone calls from project staff to patients identified from electronic medical records. Two hundred patients were recruited into the RCT (78% of those reached and eligible), with 69 and 81% reached for the 6-week and 6-month follow-ups, respectively. Women were more likely to both participate and remain in the trial, and there was a trend toward greater recruitment and retention of Spanish speakers. By engaging the community, clinicians and patients, this study was able to successfully recruit and retain a large proportion of this often difficult to reach Latino sub-population of patients with multiple chronic conditions.

Adult↗
PubMed2002

Laparoscopic surgery is not inherently dangerous for patients presenting with benign gynaecologic pathology. Results of a meta-analysis.

BACKGROUND: Laparoscopic surgery presents a large number of advantages over laparotomy. The goal of this work was to check whether these benefits outweigh any greater risk of complications. METHODS: The study design was a meta-analysis of published data from prospective randomized clinical trials (RCT). For the period 1966 to June 2000 we searched Medline and Cochrane Controlled Trial Registers and asked the investigators for further details. Meta-analysis was carried out with the Cochrane review manager software RevMan 4.1. RESULTS: A total of 27 prospective RCT including 3611 women (1809 treated by operative laparoscopy and 1802 treated by laparotomy) were enrolled in the meta-analysis. The overall risk of complications was significantly lower for patients operated by laparoscopic surgery [relative risk (RR) 0.59; 95% confidence interval (CI) 0.50-0.70]. There was no statistically significant difference concerning the risk of major complications with respect to the approach used (RR 1.0; 95% CI 0.60-1.65). The risk of minor complications was significantly lower for patients operated by laparoscopic surgery (RR 0.55; 95% CI 0.45-0.66). Concerning the risks of readmission, second procedure and blood transfusion, there was no difference between the two groups. Identical results were found when we performed a sensitivity analysis including or excluding studies according to the methodological score. Subgroup analysis according to how serious the surgery was (minor, major, advanced) showed a significant increase in the risk of transfusion for advanced procedures performed by laparotomy. CONCLUSIONS: Laparoscopic surgery is not inherently dangerous for patients presenting benign gynaecological pathologies. The potential risk of complications should no longer be advanced as an argument against using laparoscopic surgery rather than laparotomy for an operation when the indication allows the choice.

Female↗