Cephalic Vein Cutdown Is Superior to Subclavian Puncture as Venous Access for Patients with Cardiac Implantable Devices after Long-Term Follow-Up.

BACKGROUND: Cephalic vein cutdown (CVC) and subclavian vein puncture (SVP) are the most commonly used access sites for transvenous lead placement of cardiac implantable electronic devices (CIEDs). Limited knowledge exists about the long-term patency of the vascular lumen housing the leads. METHODS: Among the 2703 patients who underwent CIED procedures between 2005 and 2013, we evaluated the phlebographies of 162 patients scheduled for an elective CIED replacement (median of 6.4 years after the first operation). The phlebographies were divided into four stenosis types: Type I = 0%, Type II = 1-69%, Type III = 70-99%, and Type IV = occlusion. Due to the fact that no standardized stenosis categorization exists, experienced physicians in consensus with the involved team made the applied distribution. The primary endpoint was the occurrence of stenosis Type III or IV in the CVC group and in the SVP group. RESULTS: In total, 162 patients with venography were enrolled in this study. The prevalence of high-degree stenosis was significantly lower in the CVC group (7/89, 7.8%) than in the SVP group (15/73, 20.5%, p = 0.023). In the CVC group, venographies showed a lower median stenosis (33%) than in the SVP group (median 42%). CONCLUSIONS: The present study showed that the long-term patency of the subclavian vein is higher after CVC than after SVP for venous access in patients with CIED.

A population-based projection of psoriatic arthritis in Germany until 2050: analysis of national statutory health insurance data of 65 million German population.

The population-based prevalence of psoriatic arthritis (PsA) is still unclear and not well described globally. The aim of this study was to conduct a population-based prevalence projection and provide long-term future estimations of PsA patients in Germany until 2050, using the illness-death model and based on historical data. We analyzed the national statutory health insurance data of 65 million population in the German Institute for Medical Documentation and Information between January 2009 and December 2012. We constructed an estimation of the PsA burden among the German population using the relevant epidemiological parameters to project the numbers of patients with PsA in Germany until 2050 under five possible scenarios by varying the incidence and mortality. The overall conservatively estimated prevalence of PsA in Germany in 2019 was 0.31% (95% CI 0.28-0.36%). Women contribute a higher prevalence than men in all five scenarios. In the assumed scenarios with increased incidence, the prevalence of PsA at 60 years of age could rise from 1% in 2019 to more than 3% in 2050 for both genders, with the increase particularly pronounced for women, reaching around 3.5%. However, in the assumed scenarios with decreasing incidence, the prevalence curve may flatten and begin a decreasing trend from 2035 to 2050 for both genders, achieving a prevalence of less than 1% in 2050. Our research is to generate assumed population-based data on PsA in Germany that can serve as a reference for public health stakeholders to prepare an optional intervention. We would expect worryingly high numbers in the coming decades if preventive strategies are not implemented. In the long term, it will be necessary to implement preventive strategies to identify predictors and treat psoriasis symptoms early in order to delay or even prevent the transition of psoriasis to PsA.

Age-specific incidence of need for long-term care for men and women in Germany 2015: Cross-sectional study comprising 82 million people.

Background: With the growing number of older people, the number of people in need of long-term care is increasing, too. Official statistics only report on the age-specific prevalence of long-term care. Therefore, there is no data on the age- and sex-specific incidence of the need for care at the population level for Germany available. Methods: Analytical relationships between age-specific prevalence, incidence rate, remission rate, all-cause mortality, and mortality rate ratio are used to estimate the age-specific incidence of long-term care among men and women in 2015. The data is based on the official prevalence data from the nursing care statistics for the years 2011 to 2019 and official mortality rates from the Federal Statistical Office. For Germany, there is no data on the mortality rate ratio of people with and without a need for care, which is why we use two extreme scenarios that were obtained in a systematic literature search to estimate the incidence. Results: The age-specific incidence is about 1 per 1000 person-years (PY) in men and women at the age of 50 and increases exponentially up to the age of 90. Up to about the age of 60, men have a higher incidence rate than women. Thereafter, women have a higher incidence. At the age of 90, women and men have an incidence rate of 145 to 200 and 94 to 153 per 1000 PY, respectively, depending on the scenario. Conclusion: We estimated the age-specific incidence of the need for long-term care for women and men in Germany for the first time. We observed a strong increase, leading to a huge number of people in need of long-term care in higher age groups. It is to be expected that this will result in an increased economic burden and a further increased need for nursing and medical staff.

Perioperative complications after pacemaker implantation: higher complication rates with subclavian vein puncture than with cephalic vein cutdown.

PURPOSE: The cephalic vein cutdown (CVC) and the subclavian puncture (SP) is the most common access for pacemaker implantation. The purpose of this study was to compare the peri-/postoperative complications of these approaches. METHODS: A retrospective analysis of the quality assurance data of the state of North Rhine-Westphalia was performed to evaluate the peri-/postoperative complications of first pacemaker implantation according to the venous access. The primary endpoint was defined as the occurrence of one of the following: asystole, ventricular fibrillation, pneumothorax, hemothorax, pericardial effusion, pocket hematoma, lead dislocation, lead dysfunction, postoperative wound infection or other complication requiring intervention. Descriptive analysis was done via absolute, relative frequencies and Odds Ratio. Fisher's exact test was used for comparison of the both study groups. RESULTS: From 139,176 pacemaker implantations from 2010 to 2014, 15,483 cases were excluded due to other/double access. The median age was 78 years and the access used was CVC for 75,251 cases (60.8%) and SP for 48,442 cases (39.2%). The implanted devices were mainly dual-chamber pacemakers (73.9% in the CVC group and 78.4% in the SP group), followed by single-chamber pacemakers VVI (24.9% and 19.9% in the CVC and SP group respectively). There were significantly fewer peri/postoperative complications in the CVC group compared to the SP group (2.49% vs. 3.64%, p = 0.0001, OR 1.47; 95% CI 1.38-1.57). CONCLUSIONS: CVC as venous access for pacemaker implantation has significantly fewer peri/postoperative complications than SP and appears to be an advantageous technique.

Projected incidence trends of need for long-term care in German men and women from 2011 to 2021.

Background: The German Federal Statistical Office routinely collects and reports aggregated numbers of people in need of long-term care (NLTC) stratified by age and sex. Age- and sex-specific prevalence of NLTC from 2011 to 2021 is reported as well. One estimation of the incidence rate of NLTC based on the age- and sex-specific prevalence exists that did not explore possible trends in incidence [based on MRR (mortality rate ratio)], which is important for an adequate projection of the future number of people with NLTC. Objective: We aim to explore possible trends in age-specific incidence of NLTC in German men and women from 2011 to 2021 based on different scenarios about excess mortality (in terms of MRR). Methods: The incidence of NLTC was calculated based on an illness-death model and a related partial differential equation based on data from the Federal Statistical Office. Estimation of annual percent change (APC) of the incidence rate was conducted in eight scenarios. Results: There are consistent indications for trends in incidence for men and women aged 50-79 years with APC in incidence rate of more than +9% per year (up to nearly 19%). For ages 80+ the APC is between +0.4% and +12.5%. In all scenarios, women had higher age-specific APCs than men. Conclusion: We performed the first analysis of APC in the age- and sex-specific incidence rate of NLTC in Germany and revealed an increasing trend in the incidences. With these findings, a future prevalence of NLTC can be estimated which may exceed current prognoses.

Protocol of investigation into reporting quality of RCT abstracts on COVID-19 pursuant to CONSORT (CoCo study)-a review.

BACKGROUND: In 2020, the COVID-19 pandemic developed into a global crisis, the enormity and urgency of which accelerated research activities in the field. At the same time, manuscripts describing these research projects underwent fast-track peer review procedures and were published in freely accessible formats. Although full texts about COVID-19 are currently available for free, abstracts continue to play a key role since they provide essential information and possibly a decision basis for therapies. Abstracts are particularly important in case the full texts are not free, not all reports have been published in English and in emergency situations when there is less time for comprehensive analysis of all full texts. It is therefore necessary to ensure that abstracts-as publications in miniature format-contain comprehensive and transparent information. The CONSORT statement for abstracts (CONSORT-A) offers guidelines to authors how to include all necessary information in an abstract. Prior to the COVID-19 pandemic, the quality of reporting in medical research had already been the object of debate and criticism. The current crisis makes comprehensive documentation all the more important. Abstracts of COVID-19 RCTs should therefore report the criteria listed in the CONSORT-A statement fully and verifiably. The objective of this study is to check the completeness of abstracts of all COVID-19 RTCs published to date. METHODS: Based on a literature search in PubMed, Embase and the Cochrane Library, all publications up to 29 October 2020 are identified and examined in terms of the subject matter (reported results from COVID-19 studies) and their study design (RTC). Subsequently, suitable publications are examined for completeness and quality of abstracts. The CONSORT checklist for RTC abstracts serves as a basis in this procedure. The primary endpoint of the study is the percentage of correctly implemented items of the CONSORT statement for abstracts. The frequency of correct reporting of each individual item is checked in a second step. DISCUSSION: The study is expected to contribute to evaluating the reporting quality on COVID-19 studies, and specifically the completeness of abstracts of RTCs. It may thus support the assessment of current research into COVID-19. TRIAL REGISTRATION: Registration was not required as the study investigated existing literature.

Assessment of reporting quality in randomised controlled clinical trial abstracts of dental implantology published from 2014 to 2016.

OBJECTIVES: Access to full texts of randomised controlled clinical trials (RCTs) is often limited, so brief summaries of studies play a pivotal role. In 2008, a checklist was provided to ensure the transparency and completeness of abstracts. The aim of this investigation was to estimate adherence to the reporting guidelines of the Consolidated Standards of Reporting Trials (CONSORT) criteria for abstracts (CONSORT-A) in RCT publications. PRIMARY ENDPOINT: Assessment according to the percentage of compliance with the 16 CONSORT-A criteria per study. MATERIALS AND METHODS: This study is based on a full survey (212 RCT abstracts in dental implantology, PubMed search, publication period 2014-2016, 45 journals, median impact factor: 2.328). In addition to merely documenting 'adherence' to criteria, the authors also assessed the 'complete implementation' of the requested information where possible. The collection of data was performed independently by two dentists, and a final consensus was reached. The primary endpoint was evaluated by medians and quartiles. Additionally, a Poisson regression was conducted to detect influencing factors. RESULTS: A median of 50% (Q1-Q3: 44%-63%) was documented for the 16 criteria listed in the CONSORT-A statement. Nine of the 16 criteria were considered in fewer than 50% of the abstracts. 'Correct implementation' was achieved for a median of 43% (Q1-Q3: 31%-50%) of the criteria. An additional application of Poisson regression revealed that the number of words used had a locally significant impact on the number of reported CONSORT criteria for abstracts (incidence rate ratio 1.001, 95% CI 1.001 to 1.002). CONCLUSION: Transparent and complete reporting in abstracts appears problematic. A limited word count seems to result in a reduction in necessary information. As current scientific knowledge is often not readily available in the form of publications, abstracts constitute the primary basis for decision making in clinical practice and research. This is why journals should refrain from limiting the number of words too strictly in order to facilitate comprehensive reporting in abstracts.

Reporting of statistical sample size calculations in publications of trials on age-related macular degeneration, glaucoma and cataract.

BACKGROUND: Transparent and complete publications of randomised controlled trials (RCT) ought to comply with the guidelines of the CONSORT Statement, which stipulates sample size calculation as an important aspect of trial planning. The objective of this study was to analyse and compare the reporting of statistical sample size calculations in RCT papers on the treatment of age-related macular degeneration (AMD), glaucoma and cataract published in 2018. MATERIAL AND METHODS: This study comprises a total of 113 RCT papers (RCT-P) published in 2018 (AMD: 14, glaucoma: 28, cataract: 71), in English or German, and identified through an internet-based literature search in PubMed and EMBASE. The primary outcome measure of the study was the number of trials providing a complete description of the underlying sample case calculation on the basis of the variables required (significance level, expected outcomes, power, and resulting sample size). RESULTS: Of the RCTs reviewed, 64% (AMD), 61% (glaucoma) and 31% (cataract) provided a justification of the number of patients included. A complete description of the described studies' sample size calculation including all the necessary values (primary outcome measure of this study) was described by 21% of the AMD, 29% of the cataract and 18% of the glaucoma RCT publications (in total: 24 of 113 (21%) at a confidence interval of 95%: [13%; 29%]). CONCLUSION: All three treatment areas analysed lacked reporting quality regarding the justification of the number of patients included in a clinical trial based on a sample size calculation required for ethical reasons. More than half of all RCT publications reviewed did not provide all of the required information on statistical sample size calculation, and thus lacked transparency and completeness. It is therefore urgently required to involve methodologists in a study's planning and publishing processes to ensure that methodology descriptions are transparent and of high quality.

Prevalence of Oral and Maxillofacial Disorders in Patients with Systemic Scleroderma-A Systematic Review.

BACKGROUND: Systematic scleroderma is a rare chronic autoimmune disease of unknown aetiology. The aim of this study was to identify the prevalence of orofacial pathognomonic conditions in patients with systemic scleroderma using only randomised prospective studies that investigated the treatment of oral and maxillofacial changes, highlighted associations between the disease and Sjogren's syndrome, and/or analysed the effect of oral hygiene. METHODS: The literature was systematically reviewed based on Cochrane Library, EMBASE, PubMed, Scopus, and Web of Science articles published up to March 2020. The primary endpoint of this analysis was defined as an estimation of the prevalence of oral mucosal changes in different areas of the oral cavity (oral mucosa, tongue, lip, periodontal status, bones, and other regions) in patients suffering from scleroderma. Therefore, a systematic literature search (Cochrane Library, EMBASE, PubMed, Scopus, and Web of Science) was conducted and limited by the publication date (1950-03/2020) and the publication language (English). Extracted frequencies were pooled using methods for meta-analysis. In order to obtain the highest level of evidence, only prospective study reports were considered to be eligible. RESULTS: After full-text screening, 14 (766 patients) out of 193 publications were eligible for the final analysis. Twelve studies produced reliable results in the final data sets. Calculation of the pooled effect estimate (random effects model) revealed a prevalence of 57.6% (95% CI: 40.8-72.9%) for the main area "lip". For the area "oral mucosa", a prevalence of 35.5% (95% CI: 15.7-62.0%) was calculated. The prevalence for "other regions" was only based on studies with salivary changes and was calculated to be 25.4% (95% CI: 14.2-41.3%). CONCLUSION: The most pathognomonic conditions in the orofacial region in patients with systemic scleroderma affect the lips, oral mucosa, and salivary glands.

[Introduction of a User-oriented Application for Biometrical Sample Size Calculation in Clinical and Epidemiological Trials]. / Vorstellung eines benutzerfreundlichen Programmes zur biometrischen Fallzahlplanung in klinischen und epidemiologischen Studien.

BACKGROUND: Clinical journals strongly recommend the use of confidence intervals to present study results, since these comprise both the statistical significance and the clinical relevance of a study's outcome. However, the mandatory sample size calculations performed during a study's planning stage are mostly reported via significance test-based approaches, as there are currently only a few methods available for planning approaches via confidence intervals. As a result, many articles show a mismatch between the planning (based on significance tests) and result presentation (based on confidence intervals). To overcome this gap, a user interface will be illustrated that offers the opportunity of sample size calculation both by means of significance tests and confidence intervals, with intuitive access for clinical researchers. MATERIALS AND METHODS: Estimating sample sizes via confidence intervals requires the predetermination of the interval's maximum width, whereas the calculation of sample sizes via significance test has the minimum requirement of the test's statistical power. The resulting sample size formulas are compatible for all practically relevant cases and mainly differ in the specification of the parameters "width" and "power". For the choice of a suitable statistical power, there are established reference values (usually 80 or 90%), while the calculation of sample size by means of confidence intervals is still difficult for clinical researchers, due to the unavailability of guidelines for the choice of the interval width. The application of both approaches is demonstrated by planning a clinical trial on the rotational stability of toric intraocular lenses with or without an implemented capsular tension ring. RESULTS: A user interface was developed to implement both of the publicly accessible approaches for sample size calculation. The interface allows comparison of the approaches based on significance test and confidence interval and their interchangeability for a two-armed clinical trial design. The operator firstly chooses one of the approaches; then the necessary planning information is inputted and the calculated sample size per trial as well as the corresponding planning information for the other approach are provided. CONCLUSION: The presented sample size tool enables an intuitively accessible way to calculate sample sizes both via significance tests and via confidence intervals for two-armed study designs.

[Do Clinical Trial Publications in AMD Healthcare Provide Sufficient Information on the Underlying Samples' Baseline Characteristics to Enable Generalizability Considerations on the Trial Design?] / Berichten RCT-Publikationen zur Versorgung von AMD-Patienten Baseline-Daten zum eingebrachten Patientengut mit Blick auf die Generalisierbarkeit des Studiendesigns?

BACKGROUND: Results of RCTs must enable readers to assess applicability of the presented information into clinical routine. Therefore, the CONSORT statement's item 15 recommends explicit information on (baseline) characteristics for RCT samples. We sought to quantify the adherence to this CONSORT item by evaluation of RCTs on "age-related macular degeneration" (AMD). MATERIALS AND METHODS: A full survey comprised of 132 RCTs (01/2004 - 12/2013). Two parallel independent readers evaluated, and then consented, whether baseline characteristics as recommended were provided in the publication, and whether this information was formally and correctly presented. The evaluation was performed hierarchically in accordance to the sub-criteria of the CONSORT-statement. In the case of formally correct documentation, characteristics for age, gender, the primary clinical endpoint outcome, and the stage of AMD were checked, as well as for systemic or ophthalmological pre-existing conditions. RESULTS: 129 of 132 (98%) publications provided the documentation of baseline data, but only 67 (51%) showed a correct implementation. 77 (58%) RCT reports presented baseline data at study initiation, among which n = 67 (87%) publications presented the data stratified for samples. CONCLUSION: The implementation rate of the CONSORT criterion "baseline data" in publications appeared high. On closer inspection, publications often provided incomplete or even misleading baseline data. As a consequence, everybody in the publication process should be aware of the conditions for publishing.

[An Illustrated Guidance for the Implementation of Methodological CONSORT Criteria in the Transparent Publication of RCTs in Ophthalmology]. / Umsetzungshilfe zu methodischen Kriterien des CONSORT-Statements zur transparenten Publikation von RCTs in der Augenheilkunde.

The CONSORT Statement (Consolidated Standards of Reporting Trials) recommends an evidence-based, minimum set of recommendations for the standardised and transparent reporting of randomised clinical trials. This statement includes a checklist of 25 items on regulatory and methodological, as well as characteristics of editorial clinical trial design and results. The recommendations help authors of RCT reports to ensure the complete and transparent reporting of design and result determinants with regard to the standards of evidence-based medicine; furthermore, it seeks to enable readers to critically assess and interpret the presented information and possible limitations of the underlying study data. However, it has repeatedly been shown that the implementation of, in particular, the adherence to methodological criteria is a challenge to RCT authors. Therefore, the following overview summarises an illustrated guidance to the minimum necessary information to take into account key methodological items in the CONSORT statement.

[Influence of impact factor on reporting sample size calculations in publications on studies exemplified by AMD treatment : Cross-sectional investigation on the presence of sample size calculations in publications of RCTs on AMD treatment in journals with low and high impact factors]. / Einfluss des Impact-Faktors auf das Berichten einer Fallzahlplanung in Publikationen zu Studien am Beispiel der AMD-Therapie : Querschnittuntersuchung zum Vorliegen von Fallzahlplanungen in Publikationen von RCTs zur AMD-Therapie in Zeitschriften mit hohem und niedrigem Impact-Faktor.

BACKGROUND: For scientific and ethical reasons randomized controlled clinical trials (RCTs) should be based on a sample size calculation. The CONSORT statement, an established publication guideline for transparent study reporting, requires a sample size calculation in every study publication. OBJECTIVE: The availability of sample size calculations in RCT publications on treatment of age-related macular degeneration (AMD) was investigated. The primary hypothesis of this investigation compared the prevalence of reported sample size calculations between journals with higher (≥5) versus lower (<5) impact factors (IF). MATERIAL AND METHODS: It was examined whether information on sample size calculation was available in a series of 97 publications of RTCs on AMD treatment published between 2004 and 2014. RESULTS: Only 46 out of 97 (47%) study publications provided information on the reason for the number of patients enrolled. The comparison of publications from journals with an IF ≥ 5 (63%, 30) and from journals with an IF < 5 (40%, 67) showed a statistically significant difference of 23% in the frequencies of available sample size calculations (95% confidence interval, CI 2%; 44%). Of the publications published before 2010, 43% reported a sample size calculation versus 51% of the publications afterwards. CONCLUSION: Publications in journals with higher IF more frequently reported a sample size calculation. More than 50% of the publications did not report any sample size calculation. Authors and reviewers of publications should pay more attention to the explicit reporting of sample size calculations.

Meta-analysis of the concordance of Icare® PRO-based rebound and Goldmann applanation tonometry in glaucoma patients.

BACKGROUND: The Icare® PRO rebound tonometer is being promoted as a patient-friendly device for glaucoma detection and monitoring, allowing rapid and accurate intraocular pressure measurement avoiding anaesthesia. The aim of this systematic review was to examine the concordance of Icare® PRO and Goldmann applanation tonometry in glaucoma patients. METHODS: The German and English literature research was carried out using PubMed and Cochrane Library between January 2010 and March 2018. Method comparison trials in a paired sample study design were identified. Search criteria were 'Icare PRO', 'Rebound', 'Goldmann' and 'Applanation'. Adult patients with glaucoma of any aetiology were included. The intraindividual intraocular pressure deviation between Icare® PRO and Goldmann applanation tonometry (mm Hg) served as primary endpoint, parameterized by the reported mean differences. For each study, an asymptotic 95% confidence interval was derived. The overall intraocular pressure meta-difference (Icare® PRO-Goldmann applanation tonometry) and 95% confidence interval were estimated using the random effect model. RESULT: Of 147 publications, 6 studies (672 eyes) were included after reviewing. Four studies showed an intraocular pressure underestimation by the Icare® PRO, two an overestimation. The meta-difference (Icare® PRO-Goldmann applanation tonometry = -0.14 mm Hg; 95% confidence interval: (-0.43 mm Hg; 0.15 mm Hg)) indicated a non-significant, clinically irrelevant mean deviation (p = 0.335). The devices showed good agreement, but there was a strong heterogeneity between the studies (I² = 77%): two studies presented a significant difference (Icare® PRO-Goldmann applanation tonometry), however, with deviations in opposite directions. CONCLUSION: Although the manufacturer advertises the Icare® PRO as a 'tonometer with superior accuracy', the present review could neither confirm nor deny considerable agreement between Goldmann applanation tonometry and Icare® PRO in glaucomatous patients.

Validity of sample sizes in publications of randomised controlled trials on the treatment of age-related macular degeneration: cross-sectional evaluation.

OBJECTIVE: The aim of this cross-sectional study was to examine the completeness and accuracy of the reporting of sample size calculations in randomised controlled trial (RCT) publications on the treatment of age-related macular degeneration (AMD). METHODS: A sample of 97 RCTs published between 2004 and 2014 was reviewed for the calculation of their sample size. It was examined whether a (complete) description of the sample size calculation was presented. Furthermore, the sample size was recalculated, whenever possible based on the published details, in order to verify the reported number of patients. PRIMARY OUTCOME MEASURE: The primary endpoint of this cross-sectional investigation was a described sample size calculation that was reproducible, complete and correct (maximum tolerated deviation between reported and replicated sample size ±2 participants per trial arm). RESULTS: A total of 50 publications (52%) did not provide any information on the justification of the number of patients included. Only 17 publications (18%) provided all the necessary parameters for recalculation; 8 of 97 (8%, 95%-CI: 4% to 16%) publications achieved the primary endpoint. The median relative deviation between reported and recalculated sample sizes was 1%, with a range from -43% to +66%. CONCLUSION: Although a transparent sample size legitimation is a crucial determinant of an RCT's methodological validity, more than half of the RCT publications considered failed to report them. Furthermore, reported sample size legitimations were often incomplete or incorrect. In summary, clinical authors should pay more attention to the transparent reporting of sample size calculation, and clinical journal reviewers may opt to reproduce reported sample size calculations. SYNOPSIS: More than half of the analysed RCT publications on the treatment of AMD did not report a transparent sample size calculation. Only 8% reported a complete and correct sample size calculation.

Reporting quality of randomised controlled trial abstracts on age-related macular degeneration health care: a cross-sectional quantification of the adherence to CONSORT abstract reporting recommendations.

OBJECTIVE: To assess the reporting quality of randomised controlled trial (RCT) abstracts on age-related macular degeneration (AMD) healthcare, to evaluate the adherence to the Consolidated Standards of Reporting Trials (CONSORT) statement's recommendations on minimum abstract information and to identify journal characteristics associated with abstract reporting quality. DESIGN: Cross-sectional evaluation of RCT abstracts on AMD healthcare. METHODS: A PubMed search was implemented to identify RCT abstracts on AMD healthcare published in the English language between January 2004 and December 2013. Data extraction was performed by two parallel readers independently by means of a documentation format in accordance with the 16 items of the CONSORT checklist for abstracts. The total number of criteria fulfilled by an abstract was derived as primary endpoint of the investigation; incidence rate ratios (IRRs) with unadjusted 95% CI were estimated by means of multiple Poisson regression to identify journal and article characteristics (publication year, multicentre design, structured abstract recommendations, effective sample size, effective abstract word counts and journal impact factor) possibly associated with the total number of fulfilled items. STUDY CHARACTERISTICS: 136 of 673 identified abstracts (published in 36 different journals) fulfilled all eligibility criteria. RESULTS: The median number of fulfilled items was 7 (95% CI 7 to 8). No abstract reported all 16 recommended items; the maximum total number was 14, the minimum 3 of 16 items. Multivariate analysis only demonstrated the abstracts' word counts as being significantly associated with a better reporting of abstracts (Poisson regression-based IRR 1.002, 95% CI 1.001 to 1.003). CONCLUSIONS: Reporting quality of RCT abstracts on AMD investigations showed a considerable potential for improvement to meet the CONSORT abstract reporting recommendations. Furthermore, word counts of abstracts were identified as significantly associated with the overall abstract reporting quality.