RESUMEN
AIM: The objective of this study was to assess the efficacy of bibliotherapy for sexual dysfunctions, when compared with no treatment and compared with other interventions. METHODS: MEDLINE, EMBASE, and PsycINFO were searched from 1970 to January 2020. Selection criteria were randomized controlled trials evaluating assisted or unassisted bibliotherapy for all types of sexual dysfunctions compared with no treatment (wait list or placebo) or with other psychological interventions. Bibliotherapy is defined as psychological treatment using printed instruction to be used by the individual or couple suffering from sexual dysfunction. Primary outcome measures were male and female sexual functioning level and continuation/remission of sexual dysfunction. Secondary outcomes were sexual satisfaction and dropout rate. Sexual functioning and sexual satisfaction were self-reported by participants using validated questionnaires. RESULTS: Fifteen randomized controlled trials with a total of 1,113 participants (781 women; 332 men) met inclusion criteria. Compared with no treatment, unassisted bibliotherapy resulted in larger proportions of female participants reporting remission of sexual dysfunction, and sexual satisfaction was higher in treated participants, both female and male participants. Compared with no treatment, assisted bibliotherapy had significant positive effects on female sexual functioning; no effects on male sexual functioning were found. Results of unassisted and assisted bibliotherapy did not differ from those of other intervention types on any outcome. Throughout, no differences between study conditions were found regarding dropout rates. The certainty of the evidence for all outcomes was rated as very low. CONCLUSION: We found indications of positive effects of bibliotherapy for sexual dysfunctions. Across studies, more significant effects were found for women than for men. However, owing to limitations in the study designs and imprecision of the findings, we were unable to draw firm conclusions about the use of bibliotherapy for sexual dysfunction. More high quality and larger trials are needed. Relevant outcome measures for future studies should be defined as well as unified grading systems to measure these endpoints. In addition, future studies should report on treatment acceptability and adherence. van Lankveld JJDM, van de Wetering FT, Wylie, K et al. Bibliotherapy for Sexual Dysfunctions: A Systematic Review and Meta-Analysis. J Sex Med 2021;18:582-614.
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Biblioterapia , Disfunciones Sexuales Fisiológicas , Ansiedad , Femenino , Humanos , Masculino , Orgasmo , Disfunciones Sexuales Fisiológicas/terapia , Encuestas y CuestionariosRESUMEN
BACKGROUND: Ovarian cancer is the leading cause of death from gynaecological cancer in developed countries. Surgery and chemotherapy are considered its mainstay of treatment and the completeness of surgery is a major prognostic factor for survival in these women. Currently, computed tomography (CT) is used to preoperatively assess tumour resectability. If considered feasible, women will be scheduled for primary debulking surgery (i.e. surgical efforts to remove the bulk of tumour with the aim of leaving no visible (macroscopic) tumour). If primary debulking is not considered feasible (i.e. the tumour load is too extensive), women will receive neoadjuvant chemotherapy to reduce tumour load and subsequently undergo (interval) surgery. However, CT is imperfect in assessing tumour resectability, so additional imaging modalities can be considered to optimise treatment selection. OBJECTIVES: To assess the diagnostic accuracy of fluorodeoxyglucose-18 (FDG) PET/CT, conventional and diffusion-weighted (DW) MRI as replacement or add-on to abdominal CT, for assessing tumour resectability at primary debulking surgery in women with stage III to IV epithelial ovarian/fallopian tube/primary peritoneal cancer. SEARCH METHODS: We searched MEDLINE and Embase (OVID) for potential eligible studies (1946 to 23 February 2017). Additionally, ClinicalTrials.gov, WHO-ICTRP and the reference list of all relevant studies were searched. SELECTION CRITERIA: Diagnostic accuracy studies addressing the accuracy of preoperative FDG-PET/CT, conventional or DW-MRI on assessing tumour resectability in women with advanced stage (III to IV) epithelial ovarian/fallopian tube/primary peritoneal cancer who are scheduled to undergo primary debulking surgery. DATA COLLECTION AND ANALYSIS: Two authors independently screened titles and abstracts for relevance and inclusion, extracted data and performed methodological quality assessment using QUADAS-2. The limited number of studies did not permit meta-analyses. MAIN RESULTS: Five studies (544 participants) were included in the analysis. All studies performed the index test as replacement of abdominal CT. Two studies (366 participants) addressed the accuracy of FDG-PET/CT for assessing incomplete debulking with residual disease of any size (> 0 cm) with sensitivities of 1.0 (95% CI 0.54 to 1.0) and 0.66 (95% CI 0.60 to 0.73) and specificities of 1.0 (95% CI 0.80 to 1.0) and 0.88 (95% CI 0.80 to 0.93), respectively (low- and moderate-certainty evidence). Three studies (178 participants) investigated MRI for different target conditions, of which two investigated DW-MRI and one conventional MRI. The first study showed that DW-MRI determines incomplete debulking with residual disease of any size with a sensitivity of 0.94 (95% CI 0.83 to 0.99) and a specificity of 0.98 (95% CI 0.88 to 1.00) (low- and moderate-certainty evidence). For abdominal CT, the sensitivity for assessing incomplete debulking was 0.66 (95% CI 0.52 to 0.78) and the specificity 0.77 (95% CI 0.63 to 0.87) (low- and low-certainty evidence). The second study reported a sensitivity of DW-MRI of 0.75 (95% CI 0.35 to 0.97) and a specificity of 0.96 (95% CI 0.80 to 1.00) (very low-certainty evidence) for assessing incomplete debulking with residual disease > 1 cm. In the last study, the sensitivity for assessing incomplete debulking with residual disease of > 2 cm on conventional MRI was 0.91 (95% CI 0.59 to 1.00) and the specificity 0.97 (95% CI 0.87 to 1.00) (very low-certainty evidence). Overall, the certainty of evidence was very low to moderate (according to GRADE), mainly due to small sample sizes and imprecision. AUTHORS' CONCLUSIONS: Studies suggested a high specificity and moderate sensitivity for FDG-PET/CT and MRI to assess macroscopic incomplete debulking. However, the certainty of the evidence was insufficient to advise routine addition of FDG-PET/CT or MRI to clinical practice..In a research setting, adding an alternative imaging method could be considered for women identified as suitable for primary debulking by abdominal CT, in an attempt to filter out false-negatives (i.e. debulking, feasible based on abdominal CT, unfeasible at actual surgery).
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Imagen de Difusión por Resonancia Magnética , Neoplasias de las Trompas Uterinas/diagnóstico por imagen , Fluorodesoxiglucosa F18 , Neoplasias Ováricas/diagnóstico por imagen , Neoplasias Peritoneales/diagnóstico por imagen , Tomografía Computarizada por Tomografía de Emisión de Positrones , Radiofármacos , Neoplasias de las Trompas Uterinas/patología , Neoplasias de las Trompas Uterinas/cirugía , Estudios de Factibilidad , Femenino , Humanos , Neoplasia Residual/diagnóstico por imagen , Neoplasias Ováricas/patología , Neoplasias Ováricas/cirugía , Neoplasias Peritoneales/patología , Neoplasias Peritoneales/cirugía , Ensayos Clínicos Controlados Aleatorios como Asunto , Sensibilidad y Especificidad , Tomografía Computarizada por Rayos XRESUMEN
BACKGROUND: Treament-related diarrhoea is one of the most common and troublesome adverse effects related to chemotherapy or radiotherapy in people with cancer. Its reported incidence has been as high as 50% to 80%. Severe treatment-related diarrhoea can lead to fluid and electrolyte losses and nutritional deficiencies and could adversely affect quality of life (QoL). It is also associated with increased risk of infection in people with neutropenia due to anticancer therapy and often leads to treatment delays, dose reductions, or treatment discontinuation. Probiotics may be effective in preventing or treating chemotherapy- or radiotherapy-induced diarrhoea. OBJECTIVES: To evaluate the clinical effectiveness and side effects of probiotics used alone or combined with other agents for prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL; 2017, Issue 7), MEDLINE (1946 to July week 2, 2017), and Embase (1980 to 2017, week 30). We also searched prospective clinical trial registers and the reference lists of included studies. SELECTION CRITERIA: We included randomised controlled trials (RCTs) investigating the effects of probiotics for prevention or treatment of chemotherapy- or radiotherapy-related diarrhoea in people with cancer. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, extracted data, and assessed risk of bias. We used random-effects models for all meta-analyses. If meta-analysis was not possible, we summarised the results narratively. MAIN RESULTS: We included 12 studies involving 1554 participants. Eleven studies were prevention studies, of which seven compared probiotics with placebo (887 participants), one compared two doses of probiotics with each other and with placebo (246 participants), and three compared probiotics with another active agent (216 participants).The remaining study assessed the effectiveness of probiotics compared with placebo for treatment of radiotherapy-related diarrhoea (205 participants).For prevention of radiotherapy (with or without chemotherapy)-induced diarrhoea, review authors identified five heterogeneous placebo-controlled studies (with 926 participants analysed). Owing to heterogeneity, we could not carry out a meta-analysis, except for two outcomes. For occurrence of any diarrhoea, risk ratios (RRs) ranged from 0.35 (95% confidence interval (CI) 0.26 to 0.47) to 1.0 (95% CI 0.94 to 1.06) (three studies; low-certainty evidence). A beneficial effect of probiotics on quality of life could neither be demonstrated nor refuted (two studies; low-certainty evidence). For occurrence of grade 2 or higher diarrhoea, the pooled RR was 0.75 (95% CI 0.55 to 1.03; four studies; 420 participants; low-certainty evidence), and for grade 3 or higher diarrhoea, RRs ranged from 0.11 (95% CI 0.06 to 0.23) to 1.24 (95% CI 0.74 to 2.08) (three studies; low-certainty evidence). For probiotic users, time to rescue medication was 36 hours longer in one study (95% CI 34.7 to 37.3), but another study reported no difference (moderate-certainty evidence). For the need for rescue medication, the pooled RR was 0.50 (95% CI 0.15 to 1.66; three studies; 194 participants; very low-certainty evidence). No study reported major differences between groups with respect to adverse effects. Although not mentioned explicitly, no studies reported deaths, except one in which one participant in the probiotics group died of myocardial infarction after three sessions of radiotherapy.Three placebo-controlled studies, with 128 analysed participants, addressed prevention of chemotherapy-induced diarrhoea. For occurrence of any diarrhoea, the pooled RR was 0.59 (95% CI 0.36 to 0.96; two studies; 106 participants; low-certainty evidence). For all other outcomes, a beneficial effect of probiotics could be neither demonstrated nor refuted (one to two studies; 46 to 106 participants; all low-certainty evidence). Studies did not address quality of life nor time to rescue medication.Three studies compared probiotics with another intervention in 213 participants treated with radiotherapy (with or without chemotherapy). One very small study (21 participants) reported less diarrhoea six weeks after treatment when dietary counselling was provided (RR 0.30, 95% CI 0.11 to 0.81; very low-certainty evidence). In another study (148 participants), grade 3 or 4 diarrhoea occurred less often in the probiotics group than in the control group (guar gum containing nutritional supplement) (odds ratio (OR) 0.38, 95% CI 0.16 to 0.89; low-certainty evidence), and two studies (63 participants) found less need for rescue medication of probiotics versus another active treatment (RR 0.44, 95% CI 0.22 to 0.86; very low-certainty evidence). Studies did not address quality of life nor time to rescue medication.One placebo-controlled study with 205 participants addressed treatment for radiotherapy-induced diarrhoea and could not demonstrate or refute a beneficial effect of probiotics on average diarrhoea grade, time to rescue medication for diarrhoea (13 hours longer in the probiotics group; 95% CI -0.9 to 26.9 hours), or need for rescue medication (RR 0.74, 95% CI 0.53 to 1.03; moderate-certainty evidence). This study did not address quality of life.No studies reported serious adverse events or diarrhoea-related deaths. AUTHORS' CONCLUSIONS: This review presents limited low- or very low-certainty evidence supporting the effects of probiotics for prevention and treatment of diarrhoea related to radiotherapy (with or without chemotherapy) or chemotherapy alone, need for rescue medication, or occurrence of adverse events. All studies were underpowered and heterogeneous. Severe side effects were absent from all studies.Robust evidence on this topic must be provided by future methodologically well-designed trials.
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Diarrea/terapia , Neoplasias/tratamiento farmacológico , Neoplasias/radioterapia , Probióticos/uso terapéutico , Diarrea/complicaciones , Diarrea/prevención & control , Humanos , Placebos/uso terapéutico , Calidad de Vida , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
BACKGROUND: This is an update of a Cochrane review first published in 2002, and previously updated in 2007. Late radiation rectal problems (proctopathy) include bleeding, pain, faecal urgency, and incontinence and may develop after pelvic radiotherapy treatment for cancer. OBJECTIVES: To assess the effectiveness and safety of non-surgical interventions for managing late radiation proctopathy. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (Issue 11, 2015); MEDLINE (Ovid); EMBASE (Ovid); CANCERCD; Science Citation Index; and CINAHL from inception to November 2015. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing non-surgical interventions for the management of late radiation proctopathy in people with cancer who have undergone pelvic radiotherapy for cancer. Primary outcomes considered were: episodes of bowel activity, bleeding, pain, tenesmus, urgency, and sphincter dysfunction. DATA COLLECTION AND ANALYSIS: Study selection, 'Risk of bias' assessment, and data extraction were performed in duplicate, and any disagreements were resolved by involving a third review author. MAIN RESULTS: We identified 1221 unique references and 16 studies including 993 participants that met our inclusion criteria. One study found through the last update was moved to the 'Studies awaiting classification' section. We did not pool outcomes for a meta-analysis due to variation in study characteristics and endpoints across included studies.Since radiation proctopathy is a condition with various symptoms or combinations of symptoms, the studies were heterogeneous in their intended effect. Some studies investigated treatments targeted at bleeding only (group 1), some investigated treatments targeted at a combination of anorectal symptoms, but not a single treatment (group 2). The third group focused on the treatment of the collection of symptoms referred to as pelvic radiation disease. In order to enable some comparison of this heterogeneous collection of studies, we describe the effects in these three groups separately.Nine studies assessed treatments for rectal bleeding and were unclear or at high risk of bias. The only treatments that made a significant difference on primary outcomes were argon plasma coagulation (APC) followed by oral sucralfate versus APC with placebo (endoscopic score 6 to 9 in favour of APC with placebo, risk ratio (RR) 2.26, 95% confidence interval (CI) 1.12 to 4.55; 1 study, 122 participants, low- to moderate-quality evidence); formalin dab treatment (4%) versus sucralfate steroid retention enema (symptom score after treatment graded by the Radiation Proctopathy System Assessments Scale (RPSAS) and sigmoidoscopic score in favour of formalin (P = 0.001, effect not quantified, 1 study, 102 participants, very low- to low-quality evidence), and colonic irrigation plus ciprofloxacin and metronidazole versus formalin application (4%) (bleeding (P = 0.007, effect not quantified), urgency (P = 0.0004, effect not quantified), and diarrhoea (P = 0.007, effect not quantified) in favour of colonic irrigation (1 study, 50 participants, low-quality evidence).Three studies, of unclear and high risk of bias, assessed treatments targeted at something very localised but not a single pathology. We identified no significant differences on our primary outcomes. We graded all studies as very low-quality evidence due to unclear risk of bias and very serious imprecision.Four studies, of unclear and high risk of bias, assessed treatments targeted at more than one symptom yet confined to the anorectal region. Studies that demonstrated an effect on symptoms included: gastroenterologist-led algorithm-based treatment versus usual care (detailed self help booklet) (significant difference in favour of gastroenterologist-led algorithm-based treatment on change in Inflammatory Bowel Disease Questionnaire-Bowel (IBDQ-B) score at six months, mean difference (MD) 5.47, 95% CI 1.14 to 9.81) and nurse-led algorithm-based treatment versus usual care (significant difference in favour of the nurse-led algorithm-based treatment on change in IBDQ-B score at six months, MD 4.12, 95% CI 0.04 to 8.19) (1 study, 218 participants, low-quality evidence); hyperbaric oxygen therapy (at 2.0 atmospheres absolute) versus placebo (improvement of Subjective, Objective, Management, Analytic - Late Effects of Normal Tissue (SOMA-LENT) score in favour of hyperbaric oxygen therapy (HBOT), P = 0.0019) (1 study, 150 participants, moderate-quality evidence, retinol palmitate versus placebo (improvement in RPSAS in favour of retinol palmitate, P = 0.01) (1 study, 19 participants, low-quality evidence) and integrated Chinese traditional plus Western medicine versus Western medicine (grade 0 to 1 radio-proctopathy after treatment in favour of integrated Chinese traditional medicine, RR 2.55, 95% CI 1.30 to 5.02) (1 study, 58 participants, low-quality evidence).The level of evidence for the majority of outcomes was downgraded using GRADE to low or very low, mainly due to imprecision and study limitations. AUTHORS' CONCLUSIONS: Although some interventions for late radiation proctopathy look promising (including rectal sucralfate, metronidazole added to an anti-inflammatory regimen, and hyperbaric oxygen therapy), single small studies provide limited evidence. Furthermore, outcomes important to people with cancer, including quality of life (QoL) and long-term effects, were not well recorded. The episodic and variable nature of late radiation proctopathy requires large multi-centre placebo-controlled trials (RCTs) to establish whether treatments are effective. Future studies should address the possibility of associated injury to other gastro-intestinal, urinary, or sexual organs, known as pelvic radiation disease. The interventions, as well as the outcome parameters, should be broader and include those important to people with cancer, such as QoL evaluations.
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Proctitis/terapia , Traumatismos por Radiación/terapia , Recto/efectos de la radiación , Antiinflamatorios/uso terapéutico , Electrocoagulación/métodos , Ácidos Grasos/uso terapéutico , Formaldehído/uso terapéutico , Humanos , Oxigenoterapia Hiperbárica , Neoplasias Pélvicas/radioterapia , Ensayos Clínicos Controlados Aleatorios como Asunto , Sucralfato/uso terapéuticoRESUMEN
BACKGROUND: Systematic reviews of cost-effectiveness analyses summarize results and describe study characteristics. Variability in the study results is often explained qualitatively or based on sensitivity analyses of individual studies. However, variability due to input parameters and study characteristics (e.g., funding or study quality) is often not statistically explained. As a case study, a systematic review on the cost-effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) using meta-regression analyses is performed to explore the usefulness of such methods compared with conventional review methods. METHODS: We attempted to identify and review all modelling studies published until January 2012 that compared costs and consequences of DES versus BMS. We extracted general study information (e.g., funding), modelling methods, values of input parameters, and quality of the model using the Philips et al. checklist. Associations between study characteristics and the incremental costs and effectiveness of individual analyses were explored using regression analyses corrected for study ID. RESULTS: Sixteen eligible studies were identified, with a combined total of 508 analyses. The overall quality of the models was moderate (59% ± 15%). This study showed associations (e.g., type of lesion) that were expected (based on individual studies), however the meta-regression analyses revealed also unpredicted associations: e.g., model quality was negatively associated with repeat revascularizations avoided. CONCLUSIONS: Meta-regressions can be of added value, identifying significant associations that could not be identified using conventional review methods or by sensitivity analyses of individual studies. Furthermore, this study underlines the need to examine input parameters and perform a quality check of studies when interpreting the results.
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Análisis Costo-Beneficio , Análisis de Regresión , Análisis Costo-Beneficio/estadística & datos numéricos , Stents Liberadores de Fármacos/economíaRESUMEN
BACKGROUND: To enable older people to make decisions about the appropriateness of cardiopulmonary resuscitation (CPR), information is needed about the predictive value of pre-arrest factors such as comorbidity, functional and cognitive status on survival and quality of life of survivors. We systematically reviewed the literature to identify pre-arrest predictors for survival, quality of life and functional outcomes after out-of-hospital (OHC) CPR in the elderly. METHODS: We searched MEDLINE (through May 2011) and included studies that described adults aged 70 years and over needing CPR after OHC cardiac arrest. Prognostic factors associated with survival to discharge and quality of life of survivors were extracted. Two authors independently appraised the quality of each of the included studies. When possible a meta-analysis of odd's ratios was performed. RESULTS: Twenty-three studies were included (n = 44,582). There was substantial clinical and statistical heterogeneity and reporting was often inadequate. The pooled survival to discharge in patients >70 years was 4.1% (95% CI 3.0-5.6%). Several studies showed that increasing age was significantly associated with worse survival, but the predictive value of comorbidity was investigated in only one study. In another study, nursing home residency was independently associated with decreased chances of survival. Only a few small studies showed that age is negatively associated with a good quality of life of survivors. We were unable to perform a meta-analysis of possible predictors due to a wide variety in reporting and statistical methods. CONCLUSIONS: Although older patients have a lower chance of survival after CPR in univariate analysis (i.e. 4.1%), older age alone does not seem to be a good criterion for denying patients CPR. Evidence for the predictive value of comorbidities and for the predictive value of age on quality of life of survivors is scarce. Future studies should use uniform methods for reporting data and pre-arrest factors to increase the available evidence about pre arrest factors on the chance of survival. Furthermore, patient-specific outcomes such as quality of life and post-arrest cognitive function should be investigated too.
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Reanimación Cardiopulmonar/mortalidad , Paro Cardíaco Extrahospitalario/mortalidad , Paro Cardíaco Extrahospitalario/terapia , Anciano , Anciano de 80 o más Años , Reanimación Cardiopulmonar/tendencias , Estudios de Cohortes , Humanos , Paro Cardíaco Extrahospitalario/diagnóstico , Valor Predictivo de las Pruebas , Estudios Retrospectivos , Tasa de Supervivencia/tendencias , Resultado del TratamientoRESUMEN
OBJECTIVE: This study aimed to estimate utility values in laypeople and productivity loss for women with breast cancer in Sweden and the Netherlands. METHODS: To capture utilities, validated health state vignettes were used, which were translated into Dutch and Swedish. They described progressive disease, stable disease, and 7 grade 3/4 adverse events. One hundred members of the general public in each country rated the states using the visual analog scale and time trade-off method. To assess productivity, women who had recently completed or were currently receiving treatment for early or advanced breast cancer (the Netherlands, n = 161; Sweden, n = 52) completed the Work Productivity and Activity Impairment-General Health (WPAI-GH) questionnaire. Data were analyzed using means (SD). RESULTS: The utility study showed that the Swedish sample rated progressive and stable disease (mean, 0.61 [0.07] and 0.81 [0.05], respectively) higher than did the Dutch sample (0.49 [0.06] and 0.69 [0.05]). The health states incorporating the toxicities in both countries produced similar mean scores. Results of the WPAI-GH showed that those currently receiving treatment reported productivity reductions of 69% (the Netherlands) and 72% (Sweden); those who had recently completed therapy reported reductions of 41% (the Netherlands) and 40% (Sweden). CONCLUSIONS: The differences in the utility scores between the 2 countries underline the importance of capturing country-specific values. The significant impact of adverse events on health-related quality of life was also highlighted. The WPAI-GH results demonstrated how the negative impact of breast cancer on productivity persists after women have completed their treatment.
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Neoplasias de la Mama/terapia , Análisis Costo-Beneficio , Eficiencia , Adolescente , Adulto , Anciano , Femenino , Humanos , Persona de Mediana Edad , Países Bajos , Suecia , Adulto JovenRESUMEN
CONTEXT: Since September 2005, the International Committee of Medical Journal Editors (ICMJE) has required that randomised controlled trials (RCTs) are prospectively registered in a publicly accessible database. After registration, a trial registration number (TRN) is assigned to each RCT, which should make it easier to identify future publications and cross-check published results with associated registry entries, as long as the unique identification number is reported in the article. OBJECTIVE: Our primary objective was to evaluate the reporting of trial registration numbers in biomedical publications. Secondary objectives were to evaluate how many published RCTs had been registered and how many registered RCTs had resulted in a publication, using a sample of trials from the Netherlands Trials Register (NTR). DESIGN, SETTING: TWO DIFFERENT SAMPLES OF RCTS WERE EXAMINED: 1) RCTs published in November 2010 in core clinical journals identified in MEDLINE; 2) RCTs registered in the NTR with a latest expected end date of 31 August 2008. RESULTS: Fifty-five percent (166/302) of the reports of RCTs found in MEDLINE and 60% (186/312) of the published reports of RCTs from the NTR cohort contained a TRN. In both samples, reporting of a TRN was more likely in RCTs published in ICMJE member journals as compared to non-ICMJE member journals (MEDLINE 58% vs. 45%; NTR: 70% vs. 49%). Thirty-nine percent of published RCTs in the MEDLINE sample appear not to have been registered, and 48% of RCTs registered in the NTR seemed not to have been published at least two years after the expected date for study completion. CONCLUSION: Our results show that further promotion and implementation of trial registration and accurate reporting of TRN is still needed. This might be helped by inclusion of the TRN as an item on the CONSORT checklist.