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Effect estimates and methodological quality of randomized controlled trials about prevention of alveolar osteitis following tooth extraction: a systematic review.

OBJECTIVE: To systematically review the scientific evidence derived from randomized controlled trials (RCT) about prevention of alveolar osteitis (AO). STUDY DESIGN: Literature searches were conducted to locate RCTs about prevention of AO. The RCTs were scrutinized for methodological details and categorized according to the preventive intervention studied. Data were analyzed in relation to the frequency of AO. Absolute risk reductions (ARR), and numbers needed to treat were calculated with 95% confidence limits. RESULTS: There was a wide variation in the design and quality of the RCTs (N = 32). The greatest risk reduction for AO was seen for local treatment with tetracycline (ARR, 12%-31%). For a majority of the preventive interventions, the evidence was absent or inconclusive. CONCLUSIONS: Local treatment with tetracycline, and also 0.12% chlorhexidine rinsing preoperatively and 7 days postoperatively, seem to have significant and clinically relevant preventive effect on AO following surgical removal of lower third molars.

Anti-Bacterial Agents↗

Prognostic evaluation of primary non-small cell lung carcinoma patients using biological fluid variables. A systematic review.

We have systematically reviewed the biomedical literature to try to establish whether laboratory variables might give any additional prognostic information in non-small-cell lung cancer (NSCLC) patients independently of the usual radioclinical parameters. In each study, we acknowledged the independent prognostic value of a biological fluid variable if it had been demonstrated through a multivariate statistical analysis in which at least the following had been included: patient's weight loss, age, gender, performance status, histology, stage and extent of the disease. The clearest conclusion that can be derived from the 42 studies we reviewed is that it remains to be clearly demonstrated whether or not the "new" tests (tumour markers, p53 antibodies, etc.) are superior to the "old" tests (serum LDH, calcium, albumin or other proteins, blood cell counts, etc.), even though a number of studies did suggest that serum cyfra 21-1 has a pre-therapeutic prognostic significance in NSCLC. From the four studies in which the same powerful statistical methodologies were used (i.e. Cox models in association with RECPAM analysis), it could be derived that serum calcium and perhaps the blood neutrophil and lymphocyte counts might have independent pre-therapeutic prognostic significance in advanced NSCLC. Further studies are needed to demonstrate whether repeated measurements during therapeutic follow-up can bring any independent prognostic information. Provided that both laboratory and statistical expertise is clearly guaranteed in future primary studies published in this particular biomedical field, it might perhaps become possible to propose laboratory variables as additional prognostic parameters in NSCLC.

Biomarkers, Tumor↗

[Incisional local anesthesia as postoperative pain control after abdominal surgery. A qualitative, systematic review].

A qualitative systematic review of randomized controlled trials (RCT) of incisional local anaesthesia for the control of postoperative pain after open abdominal operations was performed. Twenty-six studies with data from 1211 patients were considered appropriate for analysis. RCT considered inguinal herniotomy, hysterectomy, cholecystectomy and 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 trials of herniotomy showed a 2-7 hour lasting, clinically relevant, improved pain relief. Five of eight cholecystectomy trials showed significant differences but in three studies of questionable clinical importance and validity. In other procedures results were inconsistent and in some cases of minor clinical importance. Except for herniotomy there is a lack of evidence for effect of incisional local anaesthesia on postoperative pain and further standardized studies are needed before recommendations can be made.

Anesthesia, Local↗

Ayurvedic medicine for rheumatoid arthritis: a systematic review.

OBJECTIVE: To systematically review all randomized controlled trials (RCTs) on the effectiveness of Ayurvedic medicine for rheumatoid arthritis (RA). METHODS: Computerized literature searches for all RCTs of Ayurvedic medicine for RA in the following databases: Medline (March 1969 to March 2003), Embase (February 1985 to February 2003), AMED (March 1980 to March 2003), Cochrane Controlled Trial Register (October 1997 to March 2003), and the abstract service of Central Council for Research in Ayurveda and Siddha (CCRAS; 1976 to March 2003). Hand searches were performed in 1 Sri Lankan and 3 Indian journals and the authors' personal files. Key data of included studies were extracted and reviewed. The methodological quality of all studies was evaluated with the Jadad scale. RESULTS: Seven studies met our inclusion criteria. Trials tested either Ayurvedic medicine against placebo or other Ayurvedic medicines. In general, patient and physician global assessments on the severity of pain, and morning stiffness were used as endpoints. Of 3 placebo-controlled RCTs, 1 high-quality trial did not show benefit of the active treatment against placebo, while another incompletely reported study indicated beneficial effects of an Ayurvedic medicine. A further incompletely reported study showed no significant difference. The remaining 4 trials were difficult to interpret because they tested an Ayurvedic medicine against other Ayurvedic medicines whose effects were not proven. CONCLUSION: There is a paucity of RCTs of Ayurvedic medicines for RA. The existing RCTs fail to show convincingly that such treatments are effective therapeutic options for RA.

Antirheumatic Agents↗

Evaluation of diagnostic assessment units in oncology: a systematic review.

PURPOSE: This systematic review was undertaken to identify clinical and economic evaluations of diagnostic assessment units for cancer; summarize measures used to evaluate such programs; and discuss the strengths and weaknesses of these evaluations. METHODS: The review was conducted to identify randomized controlled trials, case control studies, and prospective or retrospective cohort studies examining the outcomes of diagnostic centers for patients with a presumptive diagnosis of breast, colorectal, lung, head and neck, or prostate cancer. Data on methodology and study results were tabulated. RESULTS: Twenty articles were eligible for review. Eleven studies examined outcomes associated with breast cancer assessment units: six with head and neck assessment units and three with colorectal assessment units. No studies were found that examined one-stop diagnostic assessment centers for lung cancer or prostate cancer. Seventeen studies were case series, one was a case-control study, and two were randomized controlled trials. No thorough economic analyses have been undertaken. There were no studies that based their assessment on measures suggested by a conceptual framework or validated model of diagnostic care. Few studies explicitly based their investigations on established quality indicators or clinical practice guideline recommendations. Diagnostic assessment centers appear to decrease the time to arrive at a diagnosis, which in turn appears to decrease patient anxiety and increase patient satisfaction. CONCLUSION: A comprehensive understanding of the benefit of diagnostic assessment centers can only be determined if such services are developed for a variety of disease sites and more rigorous evaluations are carried out to assess their benefit.

Diagnostic Services↗

Antihypertensive therapy and incidence of type 2 diabetes: a systematic review.

OBJECTIVE: To systematically review the available evidence examining the effects of the major antihypertensive drug classes on the incidence of type 2 diabetes. RESEARCH DESIGN AND METHODS: The Cochrane Controlled Trials Register, Medline, and Embase were searched for English-language case-control, cohort, and randomized controlled trials involving the major antihypertensive classes and reporting type 2 diabetes as an end point. Reference lists of original studies and narrative reviews were also hand searched. One reviewer (R.P.) performed the electronic searches. Both reviewers independently extracted data and assessed all potentially relevant studies for inclusion and methodological quality. Abstracts were not included, and unpublished studies were not sought. RESULTS: One case-control study, 8 cohort studies, and 14 randomized controlled trials met inclusion criteria. No study examined diabetes incidence as a primary end point. Poor methodological quality limits the conclusions that can be drawn from most nonrandomized trials. Evidence from randomized studies is also potentially limited by several sources of bias, including treatment contamination and bias inherent in post hoc analyses. Data from the highest-quality studies suggest that diabetes incidence is unchanged or increased by thiazide diuretics and beta-blockers and unchanged or decreased by ACE inhibitors, calcium channel blockers, and angiotensin receptor blockers. CONCLUSIONS: The major antihypertensive classes may exert differential effects on diabetes incidence, although current data are far from conclusive. Ongoing placebo-controlled randomized trials involving potentially beneficial drug classes and examining diabetes incidence as a primary end point should provide more definitive evidence.

Antihypertensive Agents↗

Epidemiology of diabetic retinopathy and macular oedema: a systematic review.

AIMS: To systematically review the literature on the prevalence and incidence of diabetic retinopathy (DR) and macular oedema (MO). METHODS: A search of the bibliographic databases (Medline, Embase, CINAHL) was conducted up to October 2001. Selected relevant studies were scrutinized and included in the review. RESULTS: A total of 359 studies were included. The studies were reported in nearly 100 different journals and in over 50 countries. The majority of the studies were US-based, with large studies such as the Wisconsin Epidemiologic Study of Diabetic Retinopathy dominating the literature. The studies were quite dated and highly heterogeneous in nature in terms of patient selection with variable inclusion criteria (age range, gender, diabetes duration and type, ethnicity, comorbidity, and DR status, assessment, and classification). CONCLUSIONS: There are inconsistencies between epidemiological studies, and differences in study methods may contribute to conflicting reports of prevalence and incidence of DR and MO in diabetic populations. As new therapies for DR and its associated complications emerge, the need to capture and monitor new epidemiological data becomes increasingly important to be able to assess the impact and effectiveness of these therapies. Robust, longitudinal capture of patient data is, therefore, essential to evaluate the impact of current practice on the epidemiology of diabetic eye complications.

Diabetic Retinopathy↗

Barriers to participation in randomised controlled trials: a systematic review.

METHOD: A systematic review of three bibliographic databases from 1986 to 1996 identified 78 papers reporting barriers to recruitment of clinicians and patients to randomised controlled trials. RESULTS: Clinician barriers included: time constraints, lack of staff and training, worry about the impact on the doctor-patient relationship, concern for patients, loss of professional autonomy, difficulty with the consent procedure, lack of rewards and recognition, and an insufficiently interesting question. Patient barriers included: additional demands of the trial, patient preferences, worry caused by uncertainty, and concerns about information and consent. CONCLUSIONS: To overcome barriers to clinician recruitment, the trial should address an important research question and the protocol and data collection should be as straightforward as possible. The demands on clinicians and patients should be kept to a minimum. Dedicated research staff may be required to support clinical staff and patients. The recruitment aspects of a randomised controlled trial should be carefully planned and piloted. Further work is needed to quantify the extent of problems associated with clinician and patient participation, and proper evaluation is required of strategies to overcome barriers.

Data Collection↗

Crystalloids vs. colloids in fluid resuscitation: a systematic review.

OBJECTIVE: To systematically review the effects of isotonic crystalloids compared with colloids in fluid resuscitation. DATA SOURCES: Computerized bibliographic search of published research and citation review of relevant articles. STUDY SELECTION: All randomized clinical trials of adult patients requiring fluid resuscitation comparing isotonic crystalloids vs. colloids were included. Pulmonary edema, mortality, and length of stay were evaluated. Independent review of 105 articles identified 17 relevant primary studies of 814 patients. Weighted c about article inclusion was high (0.76). DATA EXTRACTION: Data on population, interventions, outcomes, and methodologic quality of the studies were obtained by duplicate independent review with differences resolved by consensus. Weighted ic on the validity assessment was moderate (0.54). DATA SYNTHESIS: No difference was observed overall between crystalloid and colloid resuscitation with respect to mortality and pulmonary edema; however, the power of the aggregated data was insufficient to detect small but potentially clinically important differences. Subgroup analysis suggested a statistically significant difference in mortality in trauma in favor of crystalloid resuscitation (relative risk 0.39, 95% confidence intervals: 0.17 to 0.89). Several methodologic issues are noteworthy regarding the primary studies, including lack of blinding (except in three studies). The type, dose, and duration of fluid administration and outcomes measured were different across these trials. CONCLUSIONS: Overall, there is no apparent difference in pulmonary edema, mortality, or length of stay between isotonic crystalloid and colloid resuscitation. Crystalloid resuscitation is associated with a lower mortality in trauma patients. Methodologic limitations preclude any evidence-based clinical recommendations. Larger well-designed randomized trials are needed to achieve sufficient power to detect potentially small differences in treatment effects if they truly exist.

Colloids↗

Interventions for steroid-resistant nephrotic syndrome: a systematic review.

In a systematic review and meta-analysis of randomized controlled trials (RCT), we aimed to evaluate the benefits and harms of all interventions for children with steroid-resistant nephrotic syndrome (SRNS). Nine RCTs involving 225 children were included. Cyclosporin when compared with placebo or no treatment significantly increased the number of children who achieved complete remission [3 trials, 49 children, relative risk (RR) for persistent nephrotic syndrome 0.64, 95% confidence intervals (CI), 0.47-0.88]. There was no significant difference in the number of children who achieved complete remission between oral cyclophosphamide with prednisone and prednisone alone [2 trials, 91 children, RR 1.01, 95% CI 0.74-1.36], between intravenous cyclophosphamide and oral cyclophosphamide [1 study, 11 children, RR 0.09, 95% CI 0.01-1.39], and between azathioprine with prednisone and prednisone alone [1 trial, 31 children, RR 1.01, 95% CI 0.77-1.32]. No RCTs were identified comparing combination regimens comprising high-dose steroids, alkylating agents or cyclosporin with single agents, placebo, or no treatment. Further adequately powered and well-designed RCTs are needed to confirm the efficacy of cyclosporin and to evaluate regimens of high-dose steroids with alkylating agents or cyclosporin for SRNS.

Child↗

Chemotherapy sensitivity and resistance assays: a systematic review.

PURPOSE: This systematic review evaluates evidence comparing therapy guided by chemotherapy sensitivity and resistance assays with empiric chemotherapy, emphasizing survival outcomes. METHODS: Prospective studies were sought comparing patients treated contemporaneously by assay-guided chemotherapy and empiric therapy. An initial MEDLINE search and a search performed by a Working Group of the American Society of Clinical Oncology were reviewed with attention to prespecified study selection criteria. RESULTS: This review identified 10 studies meeting selection criteria, plus one retrospective study, using seven different assays. Only two studies randomly assigned patients to assay-guided treatment or empiric treatment. Five of nine nonrandomized studies found significantly higher response rates for patients who received assay-guided therapy compared with those treated empirically. One of the two randomized trials found a significantly higher response rate in the assay-guided group. Four additional studies found response rates favoring assay-guided therapy, but comparisons did not achieve statistical significance. Two nonrandomized studies found overall survival to be significantly improved with assay-guided therapy. One randomized study used a cross-over design that made it difficult to determine whether survival differed between groups, while the other randomized trial found no difference in survival. Six studies provided no comparison of groups on baseline patient characteristics. Only one study reported adverse events data. CONCLUSION: While higher response rates for assay-guided therapy have been observed, differences may be attributable to bias or confounding. Little evidence on survival is available. These results do not establish the relative effectiveness of assay-guided treatment and empiric treatment. Randomized trials are needed.

Antineoplastic Agents↗

Neuroreflexotherapy for nonspecific low back pain: a systematic review.

STUDY DESIGN: Systematic review. OBJECTIVE: To assess the effectiveness of neuroreflexotherapy (NRT) for low back pain (LBP). SUMMARY OF BACKGROUND DATA: Few of the alternatives for the management of LBP have a firm base of evidence for their effectiveness. Recently, a new intervention known as NRT has been developed in Spain and has been reported to have favorable results. METHODS: Searches were undertaken according to Cochrane Collaboration guidelines, and randomized controlled trials that evaluated NRT as treatment for patients with nonspecific LBP were included. A qualitative synthesis and an assessment of methodological quality were undertaken. RESULTS: Three randomized controlled trials were included, with 125 and 148 subjects in control and intervention groups, respectively. NRT was compared with sham in two trials and standard care in one. Individuals receiving active NRT showed significantly better outcomes for pain, mobility, disability, medication use, consumption of resources, and costs. No major side effects were reported by those receiving active NRT. CONCLUSIONS: NRT appears to be a safe and effective intervention for nonspecific LBP. This conclusion is limited to three trials conducted by a small number of experienced clinicians. Further trials in other settings are needed to determine whether these favorable results can be generalized.

Acute Disease↗

Community-based programmes to prevent falls in children: a systematic review.

OBJECTIVE: We systematically reviewed the literature to examine the evidence for the effectiveness of community-based interventions to reduce fall-related injury in children aged 0-16 years. METHODS: We performed a comprehensive search of the literature using the following study selection criteria: community-based intervention study; target population was children aged 0-16 years; outcome measure was fall-related injury rates; and either a community control or historical control was used in the study design. Quality assessment and data abstraction were guided by a standardized procedure and performed independently by two authors. RESULTS: Only six studies fitting the inclusion criteria were identified in our search and only two of these used a trial design with a contemporary community control. Neither of the high quality evaluation studies showed an effect from the intervention and while authors of the remaining studies reported effective falls prevention programmes, the pre- and post-intervention design, uncontrolled for background secular trends, makes causal inferences from these studies difficult. CONCLUSION: There is a paucity of research studies from which evidence regarding the effectiveness of community-based intervention programmes for the prevention of fall-related injury in children could be based.

Accident Prevention↗

Nonsteroidal anti-inflammatory drugs and aspirin for the prevention of colorectal adenomas and cancer: a systematic review.

PURPOSE: A systematic review was conducted to determine the effect of nonsteroidal anti-inflammatory drugs for the prevention or regression of colorectal adenomas and cancer. METHODS: Randomized, controlled trials through September 2003 were identified. Nonsteroidal anti-inflammatory drugs were the interventions. The primary outcomes were the number of patients with at least one colorectal adenoma, a change in polyp burden, or colorectal cancer. The secondary outcome was adverse events. Two reviewers independently extracted data and assessed trial quality. Dichotomous outcomes were reported as relative risks with 95 percent confidence intervals. The data were combined if clinically and statistically reasonable. RESULTS: Nine trials with 150 familial adenomatous polyposis and 24,143 population patients met the inclusion criteria. The interventions included sulindac, celecoxib, or aspirin. From the combined results of three trials, significantly fewer patients in the aspirin group developed recurrent sporadic colorectal adenomas (relative risk, 0.77 (95 percent confidence interval, 0.61, 0.96), number needed to treat 12.5 (95 percent confidence interval, 7.7, 25)) after one to three years. In another three trials, patients with familial adenomatous polyposis who received nonsteroidal anti-inflammatory drugs had a greater proportional reduction (range, 11.9-44 percent) in the number of colorectal adenomas compared with those in the control group (range, 4.5-10 percent). There was no significant difference for the outcomes of colorectal cancer or adverse events in any of the trials. CONCLUSIONS: There is combined evidence from three randomized trials that aspirin significantly reduced the recurrence of sporadic adenomatous polyps. There was evidence from short-term trials to support regression, but not elimination or prevention, of colorectal polyps in familial adenomatous polyposis.

Adenoma↗

Cigarette smoking during pregnancy and risk of preeclampsia: a systematic review.

In this systematic review of the existing evidence regarding the relationship between cigarette smoking during pregnancy and preeclampsia, studies were found through searches of MEDLINE (1966-October 31, 1998), Embase, Popline, CINAHL, Lilacs, bibliographies of identified studies, and proceedings of meetings on preeclampsia, and also through contact with relevant researchers. No language restrictions were imposed. Only cohort and case-control studies dealing with the relationship between cigarette smoking and preeclampsia were considered. Assessment of methodologic quality and data extraction of each study were carried out by 2 authors working independently. Typical relative risks and odds ratios with 95% confidence intervals were calculated for cohort and case-control studies, respectively, with both fixed and random effects models. Twenty-eight cohort studies and 7 case-control studies including a total of 833,714 women were included. All cohort studies reported an inverse association between cigarette smoking during pregnancy and incidence of preeclampsia (typical relative risk, 0.68; 95% confidence interval, 0.67-0.69). The findings were similar for case-control studies (typical odds ratio, 0.68; 95% confidence interval, 0.57-0.81). An inverse dose-response relationship was also found. Pooled data from cohort and case-control studies showed a lower risk of preeclampsia associated with cigarette smoking during pregnancy.

Case-Control Studies↗

Clinicians' attitudes to clinical practice guidelines: a systematic review.

OBJECTIVE: To systematically review surveys of clinicians' attitudes to clinical practice guidelines. DATA SOURCES: MEDLINE, HealthStar, Embase and CINAHL were searched electronically for English-only surveys published from 1990 to 2000. STUDY SELECTION: We included surveys with responses to one or more of seven propositions (see below). Studies were excluded if they had fewer than 100 respondents or if the response rate was less than 60%. RESULTS: Thirty studies included responses to one or more of the seven items, giving a total of 11 611 responses. The response rate for the included studies was 72% (95% confidence interval [CI], 69%-75%). Clinicians agreed that guidelines were helpful sources of advice (weighted mean, 75%; 66%-83%), good educational tools (71%; 63%-79%) and intended to improve quality (70%; 60%-80%). However, clinicians also considered guidelines impractical and too rigid to apply to individual patients (30%; 23%-36%), that they reduced physician autonomy and oversimplified medicine (34%; 22%-47%), would increase litigation (41%; 32%-49%) and were intended to cut healthcare costs (52.8%; 39%-66%). CONCLUSIONS: Surveys of healthcare providers consistently report high satisfaction with clinical practice guidelines and a belief that they will improve quality, but there are concerns about the practicality of guidelines, their role in cost-cutting and their potential for increasing litigation.

Attitude of Health Personnel↗

The long-term effect of multidisciplinary back training: a systematic review.

STUDY DESIGN: Systematic review of randomized controlled trials. OBJECTIVES: To determine the long-term effect of multidisciplinary back training on the work participation of patients with nonspecific chronic low back pain. SUMMARY OF BACKGROUND DATA: Chronic low back pain is influenced by multiple factors. Multidisciplinary back training represents one of the options to take this multiplicity into account. So far, only evidence of the short-term effectiveness of this approach in terms of work participation is available. METHODS: Electronic databases were searched and the references of various articles were screened for relevant publications. Ten studies met the inclusion criteria. All included studies were evaluated for their methodologic quality. RESULTS: Five of the studies had a low methodologic quality. All high-quality studies found a positive effect on at least one of the 4 outcome measures used. Based on our criteria, effectiveness was found for the outcome measures of work participation and quality of life. No effectiveness was found for experienced pain and functional status. The intensity of the intervention seems to have no substantial influence on the effectiveness of the intervention. CONCLUSION: In the long-term, multidisciplinary back training has a positive effect on work participation in patients with nonspecific chronic low back pain.

Chronic Disease↗

How do parents decide on genetic testing in pediatrics? A systematic review.

PURPOSE: This systematic review aims to identify the factors that influence parents' decisions regarding pediatric diagnostic genetic testing (DT) and predictive genetic testing (PT). These factors are integrated into a conceptual decision-making model. Implications for genetic counseling, research, and ethics were derived. METHODS: PubMed, PsychInfo, WebofScience, and related references were searched for original publications between 2000 and 2023. The extracted factors were categorized using existing models. RESULTS: Of the 5843 publications, 56 met the inclusion criteria. The included studies differentiated between DT, traditional PT, and expanded PT and described factors affecting parental decisions to have the child genetically tested and to be informed about additional findings. Factors included (1) benefits/hopes, (2) worries/concerns, (3) values and beliefs, (4) individual circumstances, and (5) emotional states. CONCLUSION: Our work extends the existing empirical decision model of family decisions about genome sequencing to genetic testing in pediatrics in general, adding the categories of individual circumstances and emotional states. These factors can be further integrated into the Health Belief Model; the importance of emotional states is reflected in dual-process theories, such as the Fuzzy Trace Theory. Research is required on emotional states, differences between DT and PT, parents' decisions regarding result disclosure, and dyadic variables as decision-making predictors.

Humans↗