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[Methodological quality of an article on the treatment of gastric cancer adopted as protocol by some Chilean hospitals].

BACKGROUND: Surgery is a curative treatment for gastric cancer (GC). As relapse is frequent, adjuvant therapies such as postoperative chemo radiotherapy have been tried. In Chile, some hospitals adopted Macdonald's study as a protocol for the treatment of GC. AIM: To determine methodological quality and internal and external validity of the Macdonald study. MATERIAL AND METHOD: Three instruments were applied that assess methodological quality. A critical appraisal was done and the internal and external validity of the methodological quality was analyzed with two scales: MINCIR (Methodology and Research in Surgery), valid for therapy studies and CONSORT (Consolidated Standards of Reporting Trials), valid for randomized controlled trials (RCT). Guides and scales were applied by 5 researchers with training in clinical epidemiology. RESULTS: The reader's guide verified that the Macdonald study was not directed to answer a clearly defined question. There was random assignment, but the method used is not described and the patients were not considered until the end of the study (36% of the group with surgery plus chemo radiotherapy did not complete treatment). MINCIR scale confirmed a multicentric RCT, not blinded, with an unclear randomized sequence, erroneous sample size estimation, vague objectives and no exclusion criteria. CONSORT system proved the lack of working hypothesis and specific objectives as well as an absence of exclusion criteria and identification of the primary variable, an imprecise estimation of sample size, ambiguities in the randomization process, no blinding, an absence of statistical adjustment and the omission of a subgroup analysis. CONCLUSION: The instruments applied demonstrated methodological shortcomings that compromise the internal and external validity of the.

Antineoplastic Combined Chemotherapy Protocols↗

Design paper: the DEMO trial: a randomized, parallel-group, observer-blinded clinical trial of aerobic versus non-aerobic versus relaxation training for patients with light to moderate depression.

BACKGROUND: In western countries, the yearly incidence of depression is estimated to be 3-5% and the lifetime prevalence is 17%. In patient populations with chronic diseases the point prevalence may be 20%. Depression is associated with increased risk for various conditions such as osteoporoses, cardiovascular diseases, and dementia. WHO stated in 2000 that depression was the fourth leading cause of disease burden in terms of disability. In 2000 the cost of depression in the US was estimated to 83 billion dollars. A predominance of trials suggests that physical exercise has a positive effect on depressive symptoms. However, a meta-analysis from 2001 stated: "The effectiveness of exercise in reducing symptoms of depression cannot be determined because of a lack of good quality research on clinical populations with adequate follow-up." OBJECTIVES: The major objective for this randomized trial is to compare the effect of non-aerobic, aerobic, and relaxation training on depressive symptoms using the blindly assessed Hamilton depression scale (HAM-D(17)) as primary outcome. The secondary outcome is the effect of the intervention on working status (i.e., lost days from work, employed/unemployed) and the tertiary outcomes consist of biological responses. DESIGN: The trial is designed as a randomized, parallel-group, observer-blinded clinical trial. Patients are recruited through general practitioners and psychiatrist and randomized to three different interventions: 1) non-aerobic, -- progressive resistance training, 2) aerobic training, -- cardio respiratory fitness, and 3) relaxation training with minimal impact on strength or cardio respiratory fitness. Training for all three groups takes place twice a week for 4 months. Evaluation of patients' symptoms takes place four and 12 months after inclusion. The trial is designed to include 45 patients in each group. Statistical analysis will be done as intention to treat (all randomized patients). Results from the DEMO trial will be reported according to the CONSORT guidelines in 2008-2009.

Adolescent↗

Role of the male partner in the lower genitourinary tract infection of female.

We studied the relationships of selected microbes and the role of consorts in the causation of vaginal discharge which may be due to cervicitis or vaginitis. A total of 93 consecutive patients in the reproductive age group with symptoms of vaginal discharge along with their sexual partners were studied. Samples were collected from the cervix and posterior fornix of the female patients and from the urethra and sub-prepucial area of the male partner for culture of Neisseria gonorrhoeae, Gardnerella vaginalis, Mycoplasma hominis, ureaplasma, candida, aerobic and anaerobic organisms. Apart from cultures, KOH and Gram stain of the discharge were made. Predominant pathogen isolated was Ureaplasma urealyticum from 40 (43.01%) females and 23 (24.7%) males. The next common pathogenic organisms isolated were candida species from 11 (11.8%) females and 5 (5.4%) males and Chlamydia trachomatis in 3 (3.2%) females and 1 (1.1%) male. Various organisms were more frequently isolated from the 29 of 43 (67.4%) couples who had had sexual intercourse 7 days prior to the recruitment as compared to 14 of 43 (32.6%) who had had coitus more than 7 days prior to their recruitment. This may be due to the spontaneous disappearance or decrease in the number of organisms to the level that they could be detected by culture. In our study, 6 (6.5%) of male partners carrying pathogenic organisms were asymptomatic, indicating that their screening and treatment is vital.

Adult↗

Quality of reporting of randomized trials as a measure of methodologic quality.

CONTEXT: The evaluation of the methodologic quality of randomized controlled trials (RCTs) is central to evidence-based health care. Important methodologic detail may, however, be omitted from published reports, and the quality of reporting is therefore often used as a proxy measure for methodologic quality. We examined the relationship between reporting quality and methodologic quality of published RCTs. METHODS: Study of 60 reports of placebo-controlled trials published in English-language journals from 1985 to 1997. Reporting quality was measured using a 25-item scale based on the 1996 issue of the Consolidated Standards of Reporting Trials (CONSORT). Concealment of allocation, appropriate blinding, and analysis according to the intention-to-treat principle were indicators of methodologic quality. Methodologic quality was compared between groups of trials defined by reporting quality scores of low, intermediate, and high. Reporting quality scores were compared between groups defined by high and low methodologic quality. RESULTS: Among 23 trials of low reporting quality (median score, 9 [range, 3.5-10.5]), allocation concealment was unclear for all but 1 trial, but there were 16 trials (70%) with adequate blinding and 9 trials (39%) that had been analyzed according to the intention-to-treat principle. Among 18 trials of high reporting quality (median score, 18 [range 16.5-22.0]), there were 8 trials (44%) with adequate allocation concealment, 16 trials (89%) with adequate blinding, and 13 trials (72%) analyzed according to the intention-to-treat principle. The median reporting score was 15.0 for the 33 trials that were analyzed according to intention-to-treat principle and 14.5 for the 14 trials with on-treatment analyses (P =.67). CONCLUSIONS: Similar quality of reporting may hide important differences in methodologic quality, and well-conducted trials may be reported badly. A clear distinction should be made between these 2 dimensions of the quality of RCTs.

Publishing↗

[Immunotypes of Chlamydia trachomatis and the clinical picture of non-gonorrheal urethritis in men and cervicitis in women].

102 Chlamydia trachomatis isolates obtained from pregnant women and 42 isolates from man-consorts of women with chlamydial infection of cervix were immunotyped using a microimmunofluorescence (micro IF) with monoclonal antibodies kit (Washington Research Foundation, Seattle, USA). In both groups of patients the most common serovars were: E (37.3%) and D (24.6%) belonging to B-complex. Additional serovars noted were: F (11.3%), J (11.3%), I' (4.5%), I (3.5%, K (3.5%), G (2.8%) and H. Ba (both 0.2%). N. gonorrhoeae and/or T. vaginalis infections were more frequent from patients with B-complex Ch. trachomatis serovars (28/75 that is 37%) than C-complex Ch. trachomatis serovars (3/25 that is 12%).

Antibodies, Monoclonal↗

Pain outcomes of pediatric circumcision patients following administration of pre-operative ketorolac: A randomized clinical trial.

INTRODUCTION: Circumcision is a common surgical intervention, and pain is the most common complaint. Poorly managed pain can increase morbidity and reduce patient and parent satisfaction. Ketorolac, a non-steroidal anti-inflammatory drug (NSAID), provides analgesia and may be effective in reducing pain after circumcision in pediatric patients. STUDY OBJECTIVES: The primary objective was to determine the effect of pre-operative intravenous ketorolac versus normal saline placebo on parental perception of postoperative pain at 24 h. We also explored the effect of ketorolac on postoperative pain scores, incidence of bleeding, incidence of vomiting, and analgesic use. MATERIALS AND METHODS: A prospective, randomized, single-blinded trial was conducted at a single tertiary children's hospital. Patients aged 1-17 presenting for circumcision were included and randomized to either normal saline injectate or ketorolac (0.5 mg/kg, maximum 30 mg). Postoperative delirium and pain scores were recorded in the post-anesthetic care unit. Parents completed the parents' postoperative pain measure (PPPM) at 24 h. The CONSORT criteria and checklist were used to guide reporting of this randomized controlled trial. RESULTS: A total of 100 participants were included. 50 participants were in each group. Mean (SD) PPPM score 24 h after normal saline and ketorolac was 6.1 (3.4) and 5.5 (3.3), respectively for a mean difference of -0.55 points [95% CI: -1.9 to 0.83; p = 0.427]. The mean (95% CI) fixed effect size of ketorolac on post anesthetic care unit reported Face, Leg, Activity, Cry, Consolability score was -0.17 (-0.77 to 0.43, p = 0.585) points, while the mean (95% CI) effect size of ketorolac on numerical rating scale was -1.2 (-2.2 to -0.18, p = 0.026) points. DISCUSSION: Pre-operative intravenous ketorolac, compared to normal saline placebo, did not result in a difference in parental perception of postoperative pain at 24 h after circumcision surgery. As part of exploratory analyses, those receiving ketorolac had modestly lower mean immediate postoperative pain scores, likely not of clinical importance. Ketorolac has often been avoided due to concerns of increased bleeding risk, however it is important to consider that there is no substantial evidence to support this. This is the first study to our knowledge evaluating the effect of ketorolac in pediatric circumcision patients. While the PPPM score is a family centered outcome, it is an indirect measurement of pediatric pain. CONCLUSIONS: Pre-operative intravenous ketorolac was not associated with lower parental reported pain scores at 24 h compared to normal saline placebo after pediatric circumcision surgery. CLINICAL TRIAL REGISTRATION: NCT02973958.

Humans↗

Post-gonococcal cervicitis and post-gonococcal urethritis. A study of their epidemiological correlation and the role of Chlamydia trachomatis in their aetiology.

In a study of 157 men and 141 women with gonorrhoea post-gonococcal urethritis (PGU) in men was significantly more common among chlamydia-positive (76%) than among chlamydia-negative (22.5%) patients. Clinical investigations of PGU detected 95% of the patients infected with C trachomatis. PGU was, however, asymptomatic in over half of the patients and a careful follow-up for 3-6 weeks was necessary to detect between 80% and over 90% of cases. PGU was not related to age, past history of gonorrhoea or non-gonococcal urethritis, severity of gonococcal infection, or chlamydial inclusion count. Although post-gonococcal cervicitis (PGC) in women was an identifiable entity, it was detected in only one-third of chlamydia-positive patients. PGC was significantly associated with the 20-29 year-old age group but was not related to symptoms or chlamydial inclusion count. In the absence of facilities for culturing chlamydia, selection on an epidemiological basis of all female consorts of men with PGU, together with the remaining women with PGC, would have resulted in some unnecessary treatments and left untreated up to 30% of those harbouring C trachomatis.

Adolescent↗

Murder in the cathedral revisited: President Reagan and the mentally disabled.

A key objective of the Reagan administration when it took office in 1981 was to decrease domestic spending. Intending to offer the new administration "a little bit of a present," employees in the General Accounting Office, an arm of Congress, identified ineligible Social Security Disability Insurance (SSDI) beneficiaries as a possible source of billions of dollars of savings annually. Subsequently the administration's Office of Management and Budget instructed the Social Security Administration to begin, on an accelerated schedule, eligibility reviews authorized by the Social Security Amendments of 1980. One-fourth of the 130,500 beneficiaries dropped from the rolls during the first full year of the reviews were mentally impaired, although the mentally impaired constituted only one-ninth of SSDI beneficiaries. The reaction by mental health advocacy groups, Congress, and the courts turned "a little bit of a present" into a major problem for the administration, and the various components of government that had consorted on a misguided policy began to make amends. The experience offers useful insights for future policymaking.

Cost Control↗

Acute epididymitis: why patient and consort must be investigated.

In this prospective study of 49 patients under 35 years of age with clinically diagnosed epididymitis, detailed microbiological investigation identified an infective cause in 67%. Chlamydia trachomatis was the commonest agent, present in 25 patients, but in 12 of these detection was based solely on raised antibody titres; 20 of the 28 female consorts screened were partners of men with chlamydial epididymitis and 80% of them were also positive for this infection. Isolating the micro-organism from 14 of 16 consorts indicated active infection despite the negative swabs from the men. If this important infection is to be adequately treated we recommend that all patients in this age group with epididymitis and their partners should be referred to a specialist unit with access to full chlamydia laboratory facilities.

Acute Disease↗

[Controlled trials on the efficacy of occupational therapy with elderly. Part I: Research question, search strategy and methodological quality of trials].

OBJECTIVE: To investigate how far controlled trials give evidence for the assumption that occupational therapy treatment improves or stabilises the competence, autonomy or satisfaction of elderly while performing every day activities. METHOD: Clinical trials with randomised, quasi-experimental or crossover control group design and "occupational therapy" as the main subject were identified by an electronic search of the medline database. The criteria for the analysis were derived from the CONSORT-Statement and adapted for occupational therapy. They relate to the quality of sample, intervention, measurement and data analysis. RESULTS: The 31 identified studies (RCT, n=23; quasi-experimental, n=2; crossover, n=6) were mainly conducted in Great Britain, USA and Canada, but not in Germany. They are heterogeneous regarding the characteristics and size of samples, the outcome variables and treatment approaches. They give evidence for a significant efficacy of occupational therapy with elderly, but also show some methodological shortcomings. CONCLUSION: While on an international level the positive potential of occupational therapy for the elderly is evident, there is a strong need for further studies in Germany. Therefore a methodological harmonization and a co-operation with occupational therapy research and occupational science emerging currently in Europe are recommended.

Activities of Daily Living↗

The role of chlamydiae in genitourinary disease.

The incidence of chlamydial organisms in early morning urine specimens obtained from 53 men and 50 women without evidence of urinary tract pathology was 2 per cent in both groups. Early morning urine specimens and/or prostatic fluid or semen was examined in 50 patients with chronic prostatitis and 39 (56 per cent) yielded this organism. Of 31 patients with epididymo-orchitis the early morning urine specimens yielded chlamydiae in 12 (39 per cent) and in those with the acute form of disease the incidence was 56 per cent. The chlamydia recovery rate was 27 per cent in 119 women with cystourethritis. Within these groups of patients approximately 50 per cent of sexual partners had urine cultures positive for chlamydia. The importance of reinfection and the need for careful treatment of patients and consort should be stressed. An appropriate transport medium is necessary for specimen collection and adequate culture facilities are required to achieve effective chlamydial recovery. Trimethoprim-sulfamethoxazole and tetracycline were used effectively in the study for primary and secondary drug therapy.

Adolescent↗

Changes in beliefs identify unblinding in randomized controlled trials: a method to meet CONSORT guidelines.

Double-blinded trials are often considered the gold standard for research, but significant bias may result from unblinding of participants and investigators. Although the CONSORT guidelines discuss the importance of reporting "evidence that blinding was successful", it is unclear what constitutes appropriate evidence. Among studies reporting methods to evaluate blinding effectiveness, many have compared groups with respect to the proportions correctly identifying their intervention at the end of the trial. Instead, we reasoned that participants' beliefs, and not their correctness, are more directly associated with potential bias, especially in relation to self-reported health outcomes. During the Water Evaluation Trial performed in northern California in 1999, we investigated blinding effectiveness by sequential interrogation of participants about their "blinded" intervention assignment (active or placebo). Irrespective of group, participants showed a strong tendency to believe they had been assigned to the active intervention; this translated into a statistically significant intergroup difference in the correctness of participants' beliefs, even at the start of the trial before unblinding had a chance to occur. In addition, many participants (31%) changed their belief during the trial, suggesting that assessment of belief at a single time does not capture unblinding. Sequential measures based on either two or all eight questionnaires identified significant group-related differences in belief patterns that were not identified by the single, cross-sectional measure. In view of the relative insensitivity of cross-sectional measures, the minimal additional information in more than two assessments of beliefs and the risk of modifying participants' beliefs by repeated questioning, we conclude that the optimal means of assessing unblinding is an intergroup comparison of the change in beliefs (and not their correctness) between the start and end of a randomized controlled trial.

California↗

Contrasting relatedness patterns in bottlenose dolphins (Tursiops sp.) with different alliance strategies.

Male bottlenose dolphins (Tursiops sp.) in Shark Bay have one of the most complex male societies outside humans. Two broad mating strategies have been identified in males. In the first strategy, there are two types of alliances: stable 'first-order' pairs and trios that herd individual females in reproductive condition, and 'second-order' teams of two first-order alliances (five or six individuals) that join forces against rivals in contests for females. In the alternative strategy, a 'super-alliance' of ca. 14 individuals, males form pairs or trios to herd females, but in contrast to the stable alliances, these pairs and trios are highly labile. Here, we show that males in stable first-order alliances and the derived second-order alliances are often strongly related, so that they may gain inclusive fitness benefits from alliance membership. By contrast, members of the super-alliance are no more closely related than expected by chance. Further, the strength of the association of alliance partners within the super-alliance, as measured by an index of joint participation in consorting a female, was not correlated with their genetic relatedness. Thus, within one population and one sex, it appears that there may be simultaneous operation of more than one mode of group formation.

Animals↗

Consorting among juvenile Midas cichlids (Cichlasoma citrinellum) in relation to own and to parents' color.

Adults of the Midas cichlid, Cichlasoma citrinellum, are either normal (N) colored or gold (G); they mate assortatively by color, and that choice is influenced by prior experience with their parents. Three groups of N and two groups of G juveniles were reared by parents which were either N or G. After some months of separation from their parents, the juveniles were tested to ascertain whether the color of their parents or of their cohorts affected their affiliative responses; they were given a choice between four G and four N juveniles. There was no demonstrable effect of either their parents' or their own color. All groups spent more time with N than with G and directed more behavior toward N. The subjects differed only in that they attacked more (at a higher rate) at N and spread their fins more (at a higher rate) at G, consistent with findings in earlier studies of the effect of gold color on dominance relationships. Thus mate choice does not result from continuous associations during development.

Animals↗

Standards for Reporting Interventions in Controlled Trials of Acupuncture: the STRICTA recommendations.

Acupuncture treatment and control group interventions in parallel-group randomized trials of acupuncture are not always precisely reported. In an attempt to improve standards, an international group of experienced acupuncturists and researchers devised a set of recommendations, designating them STRICTA: STandards for Reporting Interventions in Controlled Trials of Acupuncture. In a further consensus-building round, the editors of several journals helped redraft the recommendations. These follow the Consolidated Standards for Reporting Trials (CONSORT) format, acting as an extension of the CONSORT guidelines for the specific requirements of acupuncture studies. Participating journals are publishing the STRICTA recommendations and requesting prospective authors to adhere to them when preparing reports for publication. Other journals are invited to adopt these recommendations. The intended outcome is that interventions in controlled trials of acupuncture will be more adequately reported, thereby facilitating an improvement in critical appraisal, analysis and replication of trials.

Acupuncture Therapy↗

Nicotine for schizophrenia.

BACKGROUND: The proportion of people with schizophrenia who smoke is very high, and as a rule, they tend to be heavier smokers when compared to the general population and those with other psychiatric disorders. Nicotine, the psychoactive component in tobacco, is thought to produce psychological effects that help to alleviate psychotic symptoms. OBJECTIVES: To examine the effects of nicotine and related products in the treatment of schizophrenia. SEARCH STRATEGY: We electronically searched the Cochrane Schizophrenia Group's Register (April 2005), supplemented with manually inspecting references of all identified studies and by contacting authors of studies where required. SELECTION CRITERIA: We included all randomised clinical trials comparing nicotine or related products as a sole or adjunctive treatment for people with schizophrenia or other similar serious, non-affective psychotic illness. DATA COLLECTION AND ANALYSIS: Citations and, where possible, abstracts were independently inspected by reviewers and the papers ordered were scrutinised and quality assessed. We extracted and evaluated data independently and analysed on an intention to treat basis. We would have calculated fixed effect relative risk (RR), number needed to treat/harm (NNT/H) and their 95% confidence intervals (CI) for binary outcomes and for continuous non-skewed data we would have calculated weighted mean differences. We would have excluded data if loss to follow-up had been greater than 50% and inspected the data for heterogeneity. MAIN RESULTS: We did not find any trials that met the inclusion criteria. AUTHORS' CONCLUSIONS: There ought to be further research of nicotine for schizophrenia by parallel group design randomised controlled trials investigating the effects of nicotine on symptoms of schizophrenia as well as on side effects of antipsychotic drugs. We further note that authors and journals should conform to the CONSORT guidelines when publishing the research articles, especially when disclosing all the data available from a particular study.

Antipsychotic Agents↗

Unmasking affiliative behavior among juvenile Midas cichlids (Cichlasoma citrinellum).

Adults of the Midas cichlid (Cichlasoma citrinellum) are predominantly normal-colored (N) morphs, although 8% in nature are gold (G) morphs. They tend to mate assortatively by color; that behavior may be influenced by prior experience with parents or siblings or by their own color. A previous experiment indicated that juveniles respond according to a rule that they avoid and behave defensively toward G juveniles and that they consort with and behave aggressively toward N juveniles (Barlow & Siri, 1987). The fear-provoking effect of G may have interfered with more subtle aspects of choice because the 4 treatment fish in each group reacted through the glass barrier to the approach of the subject. In the present experiment such feedback was eliminated by using one-way mirrors. N juveniles reared by normal parents (N X N) differentiated between N and G treatment fish only in that they attacked significantly more toward G; thus their behavior was contrary to that predicted by the fear-provoking effect of gold. The notable effect among juveniles reared by G parents (G X G) was that N spent more time with N and avoided G treatment fish, in keeping with the fear-provoking effect of gold. The results are discussed in terms of the differences in experiences between juveniles reared N X N, all of which were themselves N, and those reared G X G, consisting of both color morphs. Despite the differences in the two experiments, the main conclusion remains in place: Affiliative responses of juveniles, as measured in these tests, do not predict choice of mate among adults.

Aggression↗

Overview of studies of treatments for hand eczema-the EDEN hand eczema survey.

BACKGROUND: Hand eczema is a major cause of morbidity and lost earnings. Many interventions ranging from topical steroids to oral ciclosporin are used, but their evidence base and the best methods to assess their efficacy are uncertain. OBJECTIVES: As part of a long-term project to improve standards of design and reporting in hand eczema trials, we sought to describe the prevalent study designs and comment on the quality of reporting of such studies. METHODS AND DATA SOURCES: Electronic databases (Cochrane, Medline, Embase, Pascal, Jicst-Eplus, Amed) were searched from January 1977 to April 2003 using all possible variants of the terms hand and eczema/dermatitis. In addition, four general medical and 17 specialist dermatology journals were hand-searched by pairs of researchers for all possible therapeutic studies. STUDY SELECTION: Studies were eligible for inclusion if they dealt with hand eczema as diagnosed by a physician irrespective of the aetiology, and if they described the results of a study of a therapeutic intervention in humans. Single case reports and reviews were excluded, but case series and nonrandomized studies were considered alongside randomized studies. Data selection For each study, two researchers independently assessed the type of study, outcome measures, enrolment criteria, randomization, masking of interventions and how losses to follow-up were dealt with. MAIN OUTCOME MEASURES: Proportion of studies according to type of intervention and study type. Proportion of randomized controlled trials (RCTs) that adequately reported eligibility criteria, randomization generation and concealment, masking and intention-to-treat analysis. RESULTS: A total of 90 studies reported in 87 papers dealt with 11 different classes of interventions. Around 80% of the studies dealt with just four interventions: ultraviolet light, topical steroids, radiation and systemic immunosuppressives. Of the 90 studies, 44 were case series, 15 were nonrandomized controlled trials, and the remaining 31 were RCTs. Of the 31 RCTs, 16 were parallel (one with cross-over design) and 15 self-controlled. Only 11 of the RCTs adequately reported eligibility criteria. The randomization method was described in 10, and there was adequate concealment of allocation in eight. Masking the treatment allocation from both the study assessors and patients was done in 11 RCTs, and intention-to-treat analysis was reported in four. Only 13 RCTs were 4 months or longer in duration. No study reported a rationale for the sample size, and in only one study had the outcome variable been validated. CONCLUSIONS: Most 'trials' in hand eczema are not RCTs. Internally controlled (left/right) studies were common. Based on the poor overall quality of reporting, most RCTs of hand eczema trials are not adequate to guide clinical practice. Future trials of hand eczema should be randomized, using a parallel group or self-controlled design. Research is needed to develop validated and clinically relevant outcome measures. Most of the remaining issues relating to poor quality of existing evidence can be relatively easily dealt with by following the CONSORT guidelines.

Eczema↗